← Product Code [KWZ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ) · K870271

# S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP (K870271)

_Joint Medical Products Corp. · KWZ · Apr 20, 1987 · Orthopedic · SN_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K870271

## Device Facts

- **Applicant:** Joint Medical Products Corp.
- **Product Code:** [KWZ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ.md)
- **Decision Date:** Apr 20, 1987
- **Decision:** SN
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3310
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).

## Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K870271](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K870271)

**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