Product code HSD
- Device name
- Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3690
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233260 | Univers Revers CA Head and Adapter | Arthrex, Inc. | 2024-02-12 |
| K221232 | Univers Revers Humeral Cup Implant | Arthrex, Inc. | 2022-05-19 |
| K191433 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2020-11-12 |
| K193122 | Biocore9 Humeral Resurfacing System | Biocore9, LLC | 2020-05-15 |
| K173964 | OVOMotion Shoulder Arthroplasty System | Arthrosurface, Inc. | 2018-04-18 |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2016-11-21 |
| K161620 | Anatomical Shoulder Domelock Dome centric | Zimmer GmbH | 2016-11-01 |
| K151527 | Arthrex Univers Revers CA Heads and Adapters | Arthrex, Inc. | 2016-04-19 |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System | Arthrosurface, Inc. | 2014-12-19 |
| K131298 | EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM | Exactech, Inc. | 2013-11-26 |
| K130759 | HUMELOCK II CEMENTLESS SHOULDER SYSTEM | Fx Solutions | 2013-11-09 |
| K130675 | ARTHREX UNIVERS II CA HEADS | Arthrex, Inc. | 2013-10-30 |
| K130635 | SEVIIN SURFACE REPLACEMENT SHOULDER | Ingen Orthopedics, LLC | 2013-08-26 |
| K121714 | SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS | Smith & Nephew, Inc. | 2012-09-07 |
| K112900 | SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS | Lima Corporate S.P.A. | 2012-06-01 |
| K112983 | SPACER-S | Tecres S.P.A. | 2011-12-12 |
| K111097 | HUMELOCK CEMENTED SHOULDER PROSTHESIS | Fx Solutions | 2011-11-09 |
| K082715 | DEPUY GLOBAL AP CTA HUMERAL HEAD | DePuy Orthopaedics, Inc. | 2008-12-18 |
| K080990 | DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER | DePuy Orthopaedics, Inc. | 2008-08-08 |
| K073331 | DVO EXTENDED ARTICULATION HUMERAL HEADS | Dvo Extremity Solutions, LLC | 2008-02-19 |
| K072578 | SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM | Synthes (Usa) | 2007-11-28 |
| K071064 | ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA | Ascension Orthopedics, Inc. | 2007-06-22 |
| K070963 | REUNION HA FRACTURE STEM | Howmedica Osteonics Corp. | 2007-05-04 |
| K063578 | PROMOS MODULAR SHOULDER SYSTEM | Plus Orthopedics AG | 2007-03-02 |
| K062661 | AEQUALIS RESURFACING HEAD | Tornier | 2006-12-22 |
| K062845 | MODULAR REPLACEMENT ELBOW SYSTEM | Howmedica Osteonics Corp. | 2006-12-13 |
| K063081 | AEQUALIS SHOULDER SYSTEM | Tornier | 2006-11-09 |
| K062861 | ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM | Ascension Orthopedics, Inc. | 2006-10-31 |
| K061862 | AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM | Axiom Orthopaedics, Inc. | 2006-08-28 |
| K061677 | SOLAR PUREFIX HA SHOULDER | Howmedica Osteonics Corp. | 2006-07-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07611996120530 | PROMOS | Smith & Nephew, Inc. | 2016-11-03 |
| 07611996120547 | PROMOS | Smith & Nephew, Inc. | 2016-11-03 |
| 07611996120554 | PROMOS | Smith & Nephew, Inc. | 2016-11-03 |
| 07611996120523 | PROMOS | Smith & Nephew, Inc. | 2016-11-03 |
| 07613327139372 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139617 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139402 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139426 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139433 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139464 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139488 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139501 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139518 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139532 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139549 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139594 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139600 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327138160 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327138030 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327138023 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137996 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137927 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137910 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137903 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137880 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137866 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137859 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137811 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137804 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137781 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |