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substantially equivalent to a ankle balt-Chromium-Molybdenum Casting joint metal/polymer non-constrained Alloy," cemented prosthesis that was in com- (iii) ISO 5832–12:1996 "Implants for mercial distribution before May 28, Surgery-Metallic Materials -Part 12: 1976. Any other ankle joint metal/poly- Wrought Cobalt-Chromium-Molybmer non-constrained cemented pros- denum Alloy," thesis shall have an approved PMA or a (iv) ISO 5833:1992 "Implants for Surdeclared completed PDP in effect be- gery-Acrylic Resin Cements," fore being placed in commercial dis- (v) ISO 5834-2:1998 "Implants for Surtribution.

gery_Ultra High Molecular Weight

Polyethylene-Part 2: Moulded (52 FR 33702, Sept. 4, 1987, as amended at 61

Forms,” FR 50709, Sept. 27, 1996)

(vi) ISO 6018:1987 “Orthopaedic Im

Requirements for $888.3150 Elbow joint metal/polymer plants General constrained cemented prosthesis.

Marking, Packaging, and Labeling,"

(vii) ISO 9001:1994 "Quality Systems, (a) Identification. An elbow joint

Model for Quality Assurance in Design metal/polymer constrained cemented

Development, Production, Installation, prosthesis is a device intended to be

and Servicing," and implanted to replace an elbow joint. It

(viii) ISO 14630:1997 “Non-active Suris made of alloys, such as cobalt-chro

gical Implants General Requiremium-molybdenum, or of these alloys

ments," and of an ultra-high molecular weight

(3) American Society for Testing and polyethylene bushing. The device pre

Materials': vents dislocation in more than one

(i) F 75–92 “Specification for Cast Coanatomic plane and consists of two

balt-28 Chromium-6 Molybdenum Alloy components that are linked together.

for Surgical Implant Material," This generic type of device is limited

(ii) F 648–98 “Specification for Ultrato those prostheses intended for use

High-Molecular-Weight Polyethylene with bone cement (8 888.3027).

Powder and Fabricated Form for Sur(b) Classification. Class II. The special

gical Implants," controls for this device are:

(iii) F 799–96 “Specification for Co(1) FDA's:

balt-28 Chromium-6 Molybdenum Alloy (i) “Use of International Standard Forgings for Surgical Implants," ISO 10993 ‘Biological Evaluation of (iv) F 981-93 “Practice for AssessMedical Devices—Part I: Evaluation ment of Compatibility of Biomaterials and Testing,

(Nonporous) for Surgical Implant with (ii) “510(k) Sterility Review Guidance Respect to Effect of Material on Musof 2/12/90 (K90-1),”

cle and Bone," (iii) “Guidance Document for Testing (v) F 1044–95 "Test Method for Shear Orthopedic Implants with Modified Me- Testing of Porous Metal Coatings," tallic Surfaces Apposing Bone or Bone (vi) F 1108–97 “Specification for TitaCement,”

nium-6 Aluminum-4 Vanadium Alloy (iv) “Guidance Document for the Castings for Surgical Implants," Preparation of Premarket Notification (vii) F 1147-95 "Test Method for Ten(510(k)) Application for Orthopedic De- sion Testing of Porous Metal Coatings, vices,”

(v) “Guidance Document for Testing (viii) F 1537-94 "Specification for Non-articulating,

‘Mechanically

Wrought Cobalt-28 Chromium-6 MolybLocked' Modular Implant Compo- denum Alloy for Surgical Implants." nents,"

[65 FR 17147, Mar. 31, 2000) (2) International Organization for Standardization's (ISO):

$888.3160 Elbow joint metal/polymer (i) ISO 5832–3:1996 "Implants for Sur

semi-constrained cemented prosgery-Metallic Materials-Part 3: thesis. Wrought Titanium 6-Aluminum 4- (a) Identification. An elbow joint Vandium Alloy,"

metal/polymer semi-constrained ce(ii)ISO 5832 4:1996 "Implants for Sur- mented prosthesis is a device intended gery-Metallic Materials Part 4: Co- to be implanted to replace an elbow

" and

before being placed in commercial distribution. (52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996)

joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (8 888.3027).

(b) Classification. Class II.

a

or

8 888.3170 Elbow joint radial (hemi.

elbow) polymer prosthesis. (a) Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.

(b) Classification. Class II.

8888.3180 Elbow joint humeral (hemi

elbow) metallic uncemented pros

thesis. (a) Identification. An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of alloys, such as cobalt-chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulum humeri. The generic type of device is limited to prostheses intended for use without bone cement (8 888.3027).

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any elbow joint humeral (hemielbow) metallic uncemented prosthesis that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to an elbow joint humeral (hemi-elbow) metallic uncemented prosthesis that was in commercial distribution before May 28, 1976. Any other elbow joint humeral (hemi-elbow) metallic uncemented prosthesis shall have an approved PMA or a declared completed PDP in effect

$888.3200 Finger joint metalmetal

constrained uncemented prosthesis. (a) Identification. A finger joint metal/metal constrained uncemented prosthesis is a device intended to be implanted to replace metacarpophalangeal or proximal interphalangeal (finger) joint. The device prevents dislocation in more than one anatomic plane and consists of two components which are linked together. This generic type of device includes prostheses made of alloys, such as cobalt-chromium-molybdenum, protheses made from alloys and ultrahigh molecular weight polyethylene. This generic type of device is limited to prostheses intended for use without bone cement (8 888.3027).

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any finger joint metal/metal constrained uncemented prosthesis that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a finger joint metal/metal constrained uncemented prosthesis that was in commercial distribution before May 28, 1976. Any other finger joint metal/metal constrained uncemented prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. (52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996)

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tribution before May 28, 1976. Any other finger joint metal/polymer constrained cemented prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. (52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996)

or

such as cobalt-chromium-molybdenum, and is limited to those prostheses intended for with bone cement (8 888.3027).

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any finger joint metal/metal constrained cemented prosthesis that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a finger joint metal/metal constrained cemented prosthesis that was in commercial distribution before May 28, 1976. Any other finger joint metal/metal constrained cemented prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996) $ 888.3220 Finger joint metal/polymer

constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. The device prevents dislocation in more than one anatomic plane, and consists of two components which are linked together. This generic type of device include prostheses that are made of alloys, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (8 888.3027).

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a finger joint metal/polymer constrained cemented prosthesis that was in commercial dis

$ 888.3230 Finger joint polymer con.

strained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible acrossthe-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.

(b) Classification. Class II. $ 888.3300 Hip joint metal constrained

cemented uncemented pros

thesis. (a) Identification. A hip joint metal constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have components made of alloys, such as cobalt-chromium-molybdenum, and is intended for use with or without bone cement ($888.3027). This device is not intended for biological fixation.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any hip joint metal constrained cemented or uncemented prosthesis that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a hip joint metal constrained cemented or uncemented prosthesis that was in commercial distribution before May 28, 1976. Any other hip joint metal constrained cemented or uncemented prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. (52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996)

thesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (8 888.3027).

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See $888.3.

or

an

an

8 888.3310 Hip joint metal/polymer con:

strained cemented or uncemented

prosthesis. (a) Identification. A hip joint metal/ polymer constrained cemented uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and acetabular component made of ultrahigh molecular weight polyethylene. This generic type of device is intended for use with or without bone cement (8 888.3027). This device is not intended for biological fixation.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any hip joint metal/polymer constrained cemented or uncemented prosthesis that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a hip joint metal/polymer constrained mented or uncemented prosthesis that was in commercial distribution before May 28, 1976. Any other hip joint metal/ polymer constrained cemented or uncemented prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. (52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996)

$ 888.3330 Hip joint metal/metal semi

constrained, with an uncemented

acetabular component, prosthesis. (a) Identification. A hip joint metal/ metal semi-constrained, with uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (8 888.3027).

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See $888.3. $ 888.3340 Hip joirst metal/composite semi-constrained cemented

prosthesis. (a) Identification. A hip joint metal/ composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt

ce

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chromium-molybdenum, and an tabular component made of ultra-high molecular weight polyethylene with carbon fibers composite. Both components are intended for use with bone cement (888.3027).

(b) Classification. Class II.

а

8888.3350 Hip joint metal polymer

semi-constrained cemented pros

thesis. (a) Identification. A hip joint metal/ polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (8 888.3027).

(b) Classification. Class II.

8888.3358 Hip joint metal/polymer/

metal semi-constrained porous-coat

ed uncemented prosthesis. (a) Identification. A hip joint metal polymer/metal semi-constrained

porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6A1-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6A1-4V substrates, fibers of commercially pure titanium or Ti6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

(b) Classification. Class II.

or

(58 FR 3228, Jan. 8, 1993]

8 888.3353 Hip joint metal/ceramic/ polymer semi-constrained cemented nonporous

uncemented prosthesis. (a) Identification. A hip joint metal/ ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A1203) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

8 888.3360 Hip joint femoral (hemi-hip)

metallic cemented or uncemented

prosthesis. (a) Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (8 888.3027) as well as designs which have large window-like holes in the

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