21 CFR § 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

---
identifier: "/us/cfr/t21/s888.3590"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.3590"
section_name: "Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis."
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"
---


# 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

(a) *Identification.* A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).

(b) *Classification.* Class II.