HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM
Device Facts
| Record ID | K954559 |
|---|---|
| Device Name | HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM |
| Applicant | Howmedica Corp. |
| Product Code | HSD · Orthopedic |
| Decision Date | Jul 12, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3690 |
| Device Class | Class 2 |
| 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.
Indications for Use
Indicated for patients requiring proximal humerus replacement due to extensive bone loss or disease, including tumor resection, revision arthroplasty, or trauma. Intended for use with bone cement.
Regulatory Classification
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)
Related Devices
- K020045 — 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM · Biomet Orthopedics, Inc. · Jan 30, 2002
- K043505 — DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM · Biomet, Inc. · Feb 9, 2005
- K955767 — COFIED MODULAR SHOULDER SYSTEM · Smith & Nephew Richards, Inc. · Apr 8, 1996
- K111097 — HUMELOCK CEMENTED SHOULDER PROSTHESIS · Fx Solutions · Nov 9, 2011
- K143659 — Equinoxe Mega Prosthesis · Exactech, Inc. · Apr 9, 2015
