← Product Code [KWM](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWM) · K790774

# LODA WRIST PROSTHESIS (K790774)

_Depuy, Inc. · KWM · Aug 3, 1979 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWM/K790774

## Device Facts

- **Applicant:** Depuy, Inc.
- **Product Code:** [KWM](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWM.md)
- **Decision Date:** Aug 3, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3800
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist 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 either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. 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/KWM/K790774](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWM/K790774)

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