Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3560](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3560) → MBV — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

# MBV · Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

_Orthopedic · 21 CFR 888.3560 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/MBV

## Overview

- **Product Code:** MBV
- **Device Name:** Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
- **Regulation:** [21 CFR 888.3560](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3560)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

## Classification Rationale

Class II.

## Recent Cleared Devices (14 of 14)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K010212](/device/K010212.md) | OFFSET TIBIAL TRAY | Biomet, Inc. | Feb 14, 2001 | SESE |
| [K884824](/device/K884824.md) | TRICON-M TOTAL KNEE SYSTEM | Richards Medical Co., Inc. | Nov 21, 1989 | SN |
| [K873429](/device/K873429.md) | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE | Protek, Inc. | Oct 28, 1987 | SESE |
| [K853730](/device/K853730.md) | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP | Protek, Inc. | Feb 18, 1986 | SESE |
| [K833200](/device/K833200.md) | TRICON M TOTAL KNEE SYSTEM | Richards Medical Co., Inc. | Nov 29, 1983 | SESE |
| [K831441](/device/K831441.md) | POROCOAT FREEMAN/SAMUELSON TOTAL KNEE | Depuy, Inc. | Sep 1, 1983 | SESE |
| [K832302](/device/K832302.md) | MARK I TOTAL KNEE SYS. ARTHROPLASTY | Advanced Biosearch Assn. | Aug 16, 1983 | SESE |
| [K830726](/device/K830726.md) | MARK I & II TOTAL KNEE REPLACE. SYS | Advanced Biosearch Assn. | Jun 22, 1983 | SESE |
| [K823837](/device/K823837.md) | RMC TOTAL KNEE SYSTEM | Richard'S Medical Equip., Inc. | Mar 29, 1983 | SESE |
| [K830408](/device/K830408.md) | FREEMAN/SAMUELSON TOTAL KNEE | Depuy, Inc. | Feb 24, 1983 | SESE |
| [K822583](/device/K822583.md) | TOTAL KNEE SYSTEM | Richard'S Medical Equip., Inc. | Oct 4, 1982 | SESE |
| [K802921](/device/K802921.md) | ICLH TIBIAL PLATEAU | Depuy, Inc. | Jan 8, 1981 | SESE |
| [K780904](/device/K780904.md) | KNEE, TOTAL, FEMORAL & TIBIAL | Depuy, Inc. | Jun 22, 1978 | SESE |
| [K780284](/device/K780284.md) | TIBIAL PLATEU | Depuy, Inc. | Mar 15, 1978 | SESE |

## Top Applicants

- Depuy, Inc. — 5 clearances
- Advanced Biosearch Assn. — 2 clearances
- Protek, Inc. — 2 clearances
- Richard'S Medical Equip., Inc. — 2 clearances
- Richards Medical Co., Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/productcode/MBV](https://fda.innolitics.com/productcode/MBV)

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