21 CFR § 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

---
identifier: "/us/cfr/t21/s888.3565"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.3565"
section_name: "Knee joint patellofemorotibial metal/polymer porous-coated 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"
---


# 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a) *Identification.* A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

(b) *Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

[68 FR 14137, Mar. 24, 2003]