21 CFR § 888.3000 - Bone cap.

---
identifier: "/us/cfr/t21/s888.3000"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.3000 - Bone cap."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.3000"
section_name: "Bone cap."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "888"
part_name: "ORTHOPEDIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "52 FR 33702, Sept. 4, 1987, unless otherwise noted."
cfr_part: "888"
---


# 888.3000 Bone cap.

(a) *Identification.* A bone cap is a mushroom-shaped device intended to be implanted made of either silicone elastomer or ultra-high molecular weight polyethylene. It is used to cover the severed end of a long bone, such as the humerus or tibia, to control bone overgrowth in juvenile amputees.

(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38815, July 25, 2001]