← Product Code [HSD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD) · K954559

# HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM (K954559)

_Howmedica Corp. · HSD · Jul 12, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K954559

## Device Facts

- **Applicant:** Howmedica Corp.
- **Product Code:** [HSD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD.md)
- **Decision Date:** Jul 12, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3690
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

This device is a modular humeral replacement system consisting of head, body and stem segments. These segments can be combined to replace the proximal humerus secondary to extensive bone loss or bone disease. Bone loss may be due to tumor resection, revision arthroplasty or trauma. This device is indicated for use with bone cement.

## Device Story

Modular humeral replacement system; components include head, body, and stem segments. Used to replace proximal humerus following extensive bone loss from tumor resection, revision arthroplasty, or trauma. Implanted by orthopedic surgeons in clinical/surgical settings. Provides structural replacement for diseased or damaged bone; requires bone cement for fixation.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Modular system; head/stem segments: cobalt-chromium-molybdenum (Vitallium®) alloy; body segment: titanium alloy. Fixation: bone cement.

## Regulatory Identification

A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.

## Reference Devices

- Proximal Humerus Replacement (Howmedica)
- Neer II Proximal Humerus (Howmedica)
- Neer III Modular Proximal Humerus (Kirschner)
- Select Shoulder (Intermedics)
- NJ Shoulder (DePuy)
- PMI Proximal Humeral Segmental System (Biomet)
- Precision Osteolock™ Femoral Stems (Howmedica)
- P.C.A.® E-Series Hip (Howmedica)

## Submission Summary (Full Text)

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510(k) Summary K954559 JUL 12 1996

Device: Howmedica® Modular Proximal Humerus Replacement System

This device is a modular humeral replacement system consisting of head, body and stem segments. These segments can be combined to replace the proximal humerus secondary to extensive bone loss or bone disease. Bone loss may be due to tumor resection, revision arthroplasty or trauma. This device is indicated for use with bone cement.

The head and stem segments are manufactured from cobalt-chromium-molybdenum (Vitallium®) alloy. The body segment is manufactured from titanium alloy.

The Modular Proximal Humerus Replacement System has design features which are equivalent to the features of various marketed products. These equivalent products include: the Proximal Humerus Replacement (Howmedica), Neer II Proximal Humerus (Howmedica), Neer III Modular Proximal Humerus (Kirschner), Select Shoulder (Intermedics), NJ Shoulder (DePuy), PMI Proximal Humeral Segmental System (Biomet), Precision Osteolock™ Femoral Stems (Howmedica), and P.C.A.® E-Series Hip (Howmedica).

For information contact: Margaret F. Crowe
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
Telephone: (201) 507-7431
Fax: (201) 507-6870

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K954559](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K954559)

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