← Product Code [KWA](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA) · K850773

# PM CEMENTLESS SCREW-IN ACETABULAR CUP (K850773)

_Advanced Biosearch Assn. · KWA · May 2, 1985 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K850773

## Device Facts

- **Applicant:** Advanced Biosearch Assn.
- **Product Code:** [KWA](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA.md)
- **Decision Date:** May 2, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3330
- **Device Class:** Class 3
- **Review Panel:** Orthopedic

## Regulatory Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K850773](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K850773)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com