HSD · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Orthopedic · 21 CFR 888.3690 · Class 2
Overview
| Product Code | HSD |
|---|---|
| Device Name | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Regulation | 21 CFR 888.3690 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 71)
Showing 20 most recent of 71 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233260 | Univers Revers CA Head and Adapter | Arthrex, Inc. | Feb 12, 2024 | SESE |
| K221232 | Univers Revers Humeral Cup Implant | Arthrex, Inc. | May 19, 2022 | SESE |
| K191433 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | Nov 12, 2020 | SESE |
| K193122 | Biocore9 Humeral Resurfacing System | Biocore9, LLC | May 15, 2020 | SESE |
| K173964 | OVOMotion Shoulder Arthroplasty System | Arthrosurface, Inc. | Apr 18, 2018 | SESE |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | Nov 21, 2016 | SESE |
| K161620 | Anatomical Shoulder Domelock Dome centric | Zimmer GmbH | Nov 1, 2016 | SESE |
| K151527 | Arthrex Univers Revers CA Heads and Adapters | Arthrex, Inc. | Apr 19, 2016 | SESE |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System | Arthrosurface, Inc. | Dec 19, 2014 | SESE |
| K131298 | EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM | Exactech, Inc. | Nov 26, 2013 | SESE |
| K130759 | HUMELOCK II CEMENTLESS SHOULDER SYSTEM | Fx Solutions | Nov 9, 2013 | SESE |
| K130675 | ARTHREX UNIVERS II CA HEADS | Arthrex, Inc. | Oct 30, 2013 | SESE |
| K130635 | SEVIIN SURFACE REPLACEMENT SHOULDER | Ingen Orthopedics, LLC | Aug 26, 2013 | SESE |
| K121714 | SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS | Smith & Nephew, Inc. | Sep 7, 2012 | SESE |
| K112900 | SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS | Lima Corporate S.P.A. | Jun 1, 2012 | SESE |
| K112983 | SPACER-S | Tecres S.P.A. | Dec 12, 2011 | SESE |
| K111097 | HUMELOCK CEMENTED SHOULDER PROSTHESIS | Fx Solutions | Nov 9, 2011 | SESE |
| K082715 | DEPUY GLOBAL AP CTA HUMERAL HEAD | DePuy Orthopaedics, Inc. | Dec 18, 2008 | SESE |
| K080990 | DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER | DePuy Orthopaedics, Inc. | Aug 8, 2008 | SESE |
| K073331 | DVO EXTENDED ARTICULATION HUMERAL HEADS | Dvo Extremity Solutions, LLC | Feb 19, 2008 | SESE |
Top Applicants
- Howmedica Osteonics Corp. — 6 clearances
- Arthrex, Inc. — 5 clearances
- Biomet, Inc. — 4 clearances
- DePuy Orthopaedics, Inc. — 4 clearances
- Exactech, Inc. — 4 clearances
