← Product Code [MBV](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBV) · K830726

# MARK I & II TOTAL KNEE REPLACE. SYS (K830726)

_Advanced Biosearch Assn. · MBV · Jun 22, 1983 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBV/K830726

## Device Facts

- **Applicant:** Advanced Biosearch Assn.
- **Product Code:** [MBV](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBV.md)
- **Decision Date:** Jun 22, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3560
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory 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).

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBV/K830726](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBV/K830726)

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