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.
Cleared Devices (71)
| 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 |
| K072578 | SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM | Synthes (Usa) | Nov 28, 2007 | SESE |
| K071064 | ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA | Ascension Orthopedics, Inc. | Jun 22, 2007 | SESE |
| K070963 | REUNION HA FRACTURE STEM | Howmedica Osteonics Corp. | May 4, 2007 | SESE |
| K063578 | PROMOS MODULAR SHOULDER SYSTEM | Plus Orthopedics AG | Mar 2, 2007 | SESE |
| K062661 | AEQUALIS RESURFACING HEAD | Tornier | Dec 22, 2006 | SESE |
| K062845 | MODULAR REPLACEMENT ELBOW SYSTEM | Howmedica Osteonics Corp. | Dec 13, 2006 | SESE |
| K063081 | AEQUALIS SHOULDER SYSTEM | Tornier | Nov 9, 2006 | SESE |
| K062861 | ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM | Ascension Orthopedics, Inc. | Oct 31, 2006 | SESE |
| K061862 | AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM | Axiom Orthopaedics, Inc. | Aug 28, 2006 | SESE |
| K061677 | SOLAR PUREFIX HA SHOULDER | Howmedica Osteonics Corp. | Jul 10, 2006 | SESE |
| K061454 | EXACTECH EQUINOXE SHOULDER STEMS | Exactech, Inc. | Jun 12, 2006 | SESE |
| K060535 | SPACER-S TEMPORARY SHOULDER SPACER | Tecres S.P.A. | May 24, 2006 | SESE |
| K051843 | COPELAND EAS HUMERAL RESURFACING HEADS | Biomet, Inc. | Sep 29, 2005 | SESE |
| K040432 | SOLAR 2 ANATOMIC SHOULDER | Stryker Orthopaedics | Jan 7, 2005 | SESE |
| K040128 | MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS | Howmedica Osteonics Corp. | Mar 26, 2004 | SESE |
| K032126 | PROMOS SHOULDER | Plus Orthopedics | Jan 8, 2004 | SESE |
| K033516 | DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS | DePuy Orthopaedics, Inc. | Dec 3, 2003 | SESE |
| K031971 | GLOBAL CAP RESURFACING REPLACEMENT SHOULDER | DePuy Orthopaedics, Inc. | Sep 24, 2003 | SESE |
| K032264 | MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM | Howmedica Osteonics Corp. | Aug 8, 2003 | SESE |
| K023096 | CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM | Std Mfg., Inc. | Apr 10, 2003 | SESE |
| K012377 | OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES | Corin USA | Mar 11, 2002 | SESE |
| K010827 | COPELAND MB/HA RESURFACING HUMERAL HEADS | Biomet Orthopedics, Inc. | Sep 14, 2001 | SESE |
| K010657 | COPELAND MB RESURFACING HUMERAL HEADS | Biomet Manufacturing, Inc. | Sep 14, 2001 | SESE |
| K011942 | AEQUALIS PRESS-FIT SHOULDER PROSTHESIS | Tornier | Jul 13, 2001 | SESE |
| K010664 | COPELAND RESURFACING HUMERAL HEADS | Biomet Manufacturing, Inc. | Apr 5, 2001 | SESE |
| K003044 | COPELAND RESURFACING HEADS | Biomet, Inc. | Dec 13, 2000 | SESE |
| K003428 | ISS OFFSET HEADS | Biomet, Inc. | Nov 24, 2000 | SESE |
| K001419 | SOLAR SHOULDER OFFSET HUMERAL HEAD | Howmedica Osteonics Corp. | Jul 27, 2000 | SESE |
| K992525 | ACUMED MODULAR SHOULDER SYSTEM | Acu Med, Inc. | Feb 4, 2000 | SESE |
| K992394 | BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT | Endotec, Inc. | Oct 15, 1999 | SESE |
| K984202 | HOWMEDICA HUMERAL INTERCALARY SYSTEM | Howmedica, Inc. | Feb 5, 1999 | SESE |
| K982886 | OTI MODULAR SHOULDER SYSTEM | Osteoimplant Technology, Inc. | Oct 5, 1998 | SESE |
| K961260 | KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY | Biomet, Inc. | Apr 2, 1997 | SESE |
| K962289 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | Intermedics Orthopedics | Aug 29, 1996 | SESE |
| K954559 | HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM | Howmedica Corp. | Jul 12, 1996 | SESE |
| K943908 | INFINITY SHOULDER SYSTEM | Wrightmedicaltechnologyinc | May 30, 1995 | SESE |
| K950594 | HEMI-SHOULDER PROSTHESIS | Encore Orthopedics, Inc. | May 22, 1995 | SESE |
| K935593 | ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM | Biodynamic Technologies, Inc. | Oct 14, 1994 | SESE |
| K913282 | LIMA RPS SHOULDER | Turnkey Intergration USA, Inc. | Oct 21, 1991 | SESE |
| K911982 | BONE NAIL, KUNTSCHER | International Hospital Supply Co. | Jul 26, 1991 | SESE |
| K911686 | GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL | Depuy, Inc. | Jul 15, 1991 | SESE |
| K911902 | TEMPERLITE(TM) SAW BLADE | Sierra Surgical, Inc. | Jun 28, 1991 | SESE |
| K905580 | TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO | Exactech, Inc. | Mar 12, 1991 | SESE |
| K905577 | EXACTECH HUMERAL SHOULDER PROSTHESIS | Exactech, Inc. | Mar 12, 1991 | SESE |
| K874643 | KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS | Kirschner Medical Corp. | Jan 6, 1988 | SN |
| K873679 | SELECT SHOULDER SYSTEM | Intermedics Orthopedics | Nov 17, 1987 | SN |
| K873073 | KIRSCHNER NEER-III PROXIMAL HUMERUS | Kirschner Medical Corp. | Oct 1, 1987 | SN |
| K822771 | 101 NEER TYPE SHOULDER | Intermedics Orthopedics | Oct 6, 1982 | SESE |
| K802123 | MONOSPHERICAL SHOULDER PROSTHESIS | Howmedica Corp. | Sep 16, 1980 | SESE |
| K800494 | NEW JERSEY HEMIARTHROPLASTY SHOLDER PROS | Depuy, Inc. | Mar 18, 1980 | SESE |
| K791548 | REXTON HS(HEARING SYSTEM) | Argosy Intl. (Usa), Inc. | Sep 28, 1979 | SESE |
Top Applicants
- Howmedica Osteonics Corp. — 6 clearances
- Arthrex, Inc. — 5 clearances
- Exactech, Inc. — 4 clearances
- DePuy Orthopaedics, Inc. — 4 clearances
- Biomet, Inc. — 4 clearances
