C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 888—ORTHOPEDIC DEVICES › Subpart D—Prosthetic Devices

21 C.F.R. § 888.3030

Single/multiple component metallic bone fixation appliances and accessories

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(a) Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

(b) Classification. Class II.

Notes of Decisions
Cited in 2 cases, 1995–1995 · leading case: Rosci v. AcroMed, Inc., 669 A.2d 959 (Pa. Super. Ct. 1995).
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Rosci v. AcroMed, Inc., 669 A.2d 959 (Pa. Super. Ct. 1995). · cites it 2× “§ 360e(a), the MDAs grandfathered into the market all devices introduced before May 28, 1976, the effective date of the Act, see: 21 U.”
Burgstahler v. AcroMed Corp., 670 A.2d 658 (Pa. Super. Ct. 1995). “21 C.F.R. § 888.3030 . Other than this identification and classification regulation, the parties have not directed this Court to, nor have we found, any other FDA regulations specifically applicable to long bone screws and plates.”
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