Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3310](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3310) → PBI — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive

# PBI · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive

_Orthopedic · 21 CFR 888.3310 · Class 2_

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

## Overview

- **Product Code:** PBI
- **Device Name:** Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
- **Regulation:** [21 CFR 888.3310](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3310)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## 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).

## Classification Rationale

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.”

## 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.”

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K212512](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PBI/K212512.md) | G7® Vivacit-E® Freedom® Constrained Liner | Zimmer, Inc. | Apr 28, 2022 | SESE |
| [K121874](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PBI/K121874.md) | G7 ACETABULAR SYSTEM | Biomet Manufacturing Corp | Nov 23, 2012 | SESE |

## Top Applicants

- Zimmer, Inc. — 1 clearance
- Biomet Manufacturing Corp — 1 clearance

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

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