is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe. (b) Classification. Class II. § 888.3750 Wrist joint carpal lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal lunate bone of the wrist. (b) Classification. Class II. § 888.3760 Wrist joint carpal scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal scaphoid bone of the wrist. (b) Classification. Class II. § 888.3770 Wrist joint carpal trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist. (b) Classification. Class II. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of polyester-reinforced silicone elastomer intended to be implanted to replace a wrist joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane. (b) Classification. Class II. § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device prevents dislocation in more than one anatomic plane and consists of either a single flexible across-the-joint component or two components linked to gether. This generic type of device is limited to a device which is made of alloys, such as cobalt-chromium-molybdenum, and is limited to those prostheses intended for use with bone cement (§ 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. ce § 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained mented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-thejoint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027). (b) Classification. Class II. § 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis. (a) Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus. (b) Classification. Class II. Subpart E-Surgical Devices § 888.4150 Calipers for clinical use. (a) Identification. A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis. (b) Classification. Class I. The device is exempt from the premarket notification procedures in Subpart E of Part 807. § 888.4200 Cement dispenser. (a) Identification. A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites. (b) Classification. Class I. If the device is made of the same materials that were used in the device before May 28, 1976 (e.g., 316 stainless steel, chrome plated carbon steel, or polyethylene), the device is exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52953, Dec. 29, 1988] § 888.4210 Cement mixer for clinical use. (a) Identification. A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (§ 888.3027). (b) Classification. Class I. If the device is made of the same materials that were used in the device before May 28, 1976 (e.g., 316 stainless steel or polyethylene), the device is exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52953, Dec. 29, 1988] § 888.4220 Cement monomer vapor evacuator. (a) Identification. A cement monomer vapor evacuator is a device intended for use during surgery to contain or remove undesirable fumes, such as monomer vapor from bone cement (§ 888.3027). (b) Classification. Class I. The device is exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988] § 888.4230 Cement ventilation tube. (a) Identification. A cement ventilation tube is a tube-like device usually made of plastic intended to be inserted into a surgical cavity to allow the release of air or fluid from the cavity as it is being filled with bone cement (§ 888.3027). (b) Classification. Class I. If the device is made of the same materials that were used in the device before May 28, 1976 (e.g., polypropylene or polyethylene), the device is exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988] 888.4300 Depth gauge for clinical use. (a) Identification. A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone. (b) Classification. Class I. The device is exempt from the premarket notification procedures in Subpart E of Part 807. § 888.4540 Orthopedic manual surgical instrument. (a) Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench. (b) Classification. Class I. If the device is made of the same materials that were used in the device before May 28, 1976, the device is exempt from the premarket notification procedures in Subpart E of Part 807. § 888.4580 Sonic surgical instrument and accessories/attachments. (a) Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic. (b) Classification. Class II. § 888.4600 Protractor for clinical use. (a) Identification. A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on X-rays or in surgery. (b) Classification. Class I. The device is exempt from the premarket notification procedures in Subpart E of Part 807. § 888.4800 Template for clinical use. (a) Identification. A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting. (b) Classification. Class I. The device is exempt from the premarket notification procedures in Subpart E of Part 807. § 888.5850 Nonpowered orthopedic traction apparatus and accessories. (a) Identification. A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system. (b) Classification. Class I. The device is exempt from the premarket notification procedures in Subpart E of Part 807. The device is exempt from the current good manufacturing practice regulations in Part 820 with the exception of § 820.180, regarding gen eral requirements concerning records, and § 820.198, regarding complaint files. § 888.5890 Noninvasive traction component. (a) Identification. A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body. (b) Classification. Class I. The device is exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. The device is exempt from the current good manufacturing practice regulations in Part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files. [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988] § 888.5940 Cast component. (a) Identification. A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron. (b) Classification. Class I. If the device is made of the same materials that were used in the device before May 28, 1976, (e.g., heels of rubber vinyl; walking irons of plate steel) it is exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. The device is exempt from the current good manufacturing practice regulations in Part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files. [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988] § 888.5980 Manual cast application and removal instrument. (a) Identification. A manual cast application and removal instrument is a nonpowered hand-held device intended to be used in applying or removing a cast. This generic type of device in Sec. 890.5700 Cold pack. 890.5710 Hot or cold disposable pack. 890.5720 Water circulating hot or cold pack. 890.5730 Moist heat pack. 890.5740 Powered heating pad. 890.5765 Pressure-applying device. 890.5850 Powered muscle stimulator. 890.5860 Ultrasound and muscle stimulator. 390.5880 Multi-function physical therapy table. 890.5900 Powered traction equipment. 890.5925 Traction accessory. 890.5940 Chilling unit. 890.5950 Powered heating unit. 890.5975 Therapeutic vibrator. AUTHORITY: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371). SOURCE: 48 FR 53047, Nov. 23, 1983, unless otherwise noted. Subpart A-General Provisions § 890.1 Scope. (a) This part sets forth the classification of physical medicine devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under Part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87. (c) To avoid duplicative listings, a physical medicine device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart. (d) References in this part to regulatory sections of the Code of Federal Regulations are the Chapter I of Title 21, unless otherwise noted. [52 FR 17741, May 11, 1987] § 890.3 Effective dates of requirement for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application of premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, includiing a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the |