FDA Product Code
FDA Product Code HSD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3690
510(k) Clearances — 71 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233260 | Univers Revers CA Head and Adapter | Arthrex, Inc. | 2024-02-12 | Traditional | PDF ↗ |
| K221232 | Univers Revers Humeral Cup Implant | Arthrex, Inc. | 2022-05-19 | Special | PDF ↗ |
| K191433 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2020-11-12 | Traditional | PDF ↗ |
| K193122 | Biocore9 Humeral Resurfacing System | Biocore9, LLC | 2020-05-15 | Traditional | PDF ↗ |
| K173964 | OVOMotion Shoulder Arthroplasty System | Arthrosurface, Inc. | 2018-04-18 | Traditional | PDF ↗ |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2016-11-21 | Traditional | PDF ↗ |
| K161620 | Anatomical Shoulder Domelock Dome centric | Zimmer GmbH | 2016-11-01 | Traditional | PDF ↗ |
| K151527 | Arthrex Univers Revers CA Heads and Adapters | Arthrex, Inc. | 2016-04-19 | Traditional | PDF ↗ |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System | Arthrosurface, Inc. | 2014-12-19 | Special | PDF ↗ |
| K131298 | EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM | Exactech, Inc. | 2013-11-26 | Traditional | PDF ↗ |
| K130759 | HUMELOCK II CEMENTLESS SHOULDER SYSTEM | Fx Solutions | 2013-11-09 | Traditional | PDF ↗ |
| K130675 | ARTHREX UNIVERS II CA HEADS | Arthrex, Inc. | 2013-10-30 | Traditional | PDF ↗ |
| K130635 | SEVIIN SURFACE REPLACEMENT SHOULDER | Ingen Orthopedics, LLC | 2013-08-26 | Traditional | PDF ↗ |
| K121714 | SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS | Smith & Nephew, Inc. | 2012-09-07 | Traditional | PDF ↗ |
| K112900 | SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS | Lima Corporate S.P.A. | 2012-06-01 | Traditional | PDF ↗ |
| K112983 | SPACER-S | Tecres S.P.A. | 2011-12-12 | Traditional | PDF ↗ |
| K111097 | HUMELOCK CEMENTED SHOULDER PROSTHESIS | Fx Solutions | 2011-11-09 | Traditional | PDF ↗ |
| K082715 | DEPUY GLOBAL AP CTA HUMERAL HEAD | DePuy Orthopaedics, Inc. | 2008-12-18 | Special | PDF ↗ |
| K080990 | DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER | DePuy Orthopaedics, Inc. | 2008-08-08 | Traditional | PDF ↗ |
| K073331 | DVO EXTENDED ARTICULATION HUMERAL HEADS | Dvo Extremity Solutions, LLC | 2008-02-19 | Traditional | PDF ↗ |
| K072578 | SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM | Synthes (Usa) | 2007-11-28 | Traditional | PDF ↗ |
| K071064 | ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA | Ascension Orthopedics, Inc. | 2007-06-22 | Traditional | PDF ↗ |
| K070963 | REUNION HA FRACTURE STEM | Howmedica Osteonics Corp. | 2007-05-04 | Special | PDF ↗ |
| K063578 | PROMOS MODULAR SHOULDER SYSTEM | Plus Orthopedics AG | 2007-03-02 | Traditional | PDF ↗ |
| K062661 | AEQUALIS RESURFACING HEAD | Tornier | 2006-12-22 | Traditional | PDF ↗ |
| K062845 | MODULAR REPLACEMENT ELBOW SYSTEM | Howmedica Osteonics Corp. | 2006-12-13 | Traditional | PDF ↗ |
| K063081 | AEQUALIS SHOULDER SYSTEM | Tornier | 2006-11-09 | Special | PDF ↗ |
| K062861 | ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM | Ascension Orthopedics, Inc. | 2006-10-31 | Traditional | PDF ↗ |
| K061862 | AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM | Axiom Orthopaedics, Inc. | 2006-08-28 | Traditional | PDF ↗ |
| K061677 | SOLAR PUREFIX HA SHOULDER | Howmedica Osteonics Corp. | 2006-07-10 | Special | PDF ↗ |
| K061454 | EXACTECH EQUINOXE SHOULDER STEMS | Exactech, Inc. | 2006-06-12 | Special | PDF ↗ |
| K060535 | SPACER-S TEMPORARY SHOULDER SPACER | Tecres S.P.A. | 2006-05-24 | Traditional | PDF ↗ |
| K051843 | COPELAND EAS HUMERAL RESURFACING HEADS | Biomet, Inc. | 2005-09-29 | Traditional | PDF ↗ |
| K040432 | SOLAR 2 ANATOMIC SHOULDER | Stryker Orthopaedics | 2005-01-07 | Traditional | PDF ↗ |
| K040128 | MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS | Howmedica Osteonics Corp. | 2004-03-26 | Special | PDF ↗ |
| K032126 | PROMOS SHOULDER | Plus Orthopedics | 2004-01-08 | Traditional | PDF ↗ |
| K033516 | DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS | DePuy Orthopaedics, Inc. | 2003-12-03 | Special | PDF ↗ |
| K031971 | GLOBAL CAP RESURFACING REPLACEMENT SHOULDER | DePuy Orthopaedics, Inc. | 2003-09-24 | Traditional | PDF ↗ |
| K032264 | MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM | Howmedica Osteonics Corp. | 2003-08-08 | Special | PDF ↗ |
| K023096 | CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM | Std Mfg., Inc. | 2003-04-10 | Traditional | PDF ↗ |
| K012377 | OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES | Corin USA | 2002-03-11 | Traditional | PDF ↗ |
| K010657 | COPELAND MB RESURFACING HUMERAL HEADS | Biomet Manufacturing, Inc. | 2001-09-14 | Traditional | PDF ↗ |
| K010827 | COPELAND MB/HA RESURFACING HUMERAL HEADS | Biomet Orthopedics, Inc. | 2001-09-14 | Traditional | PDF ↗ |
| K011942 | AEQUALIS PRESS-FIT SHOULDER PROSTHESIS | Tornier | 2001-07-13 | Special | PDF ↗ |
| K010664 | COPELAND RESURFACING HUMERAL HEADS | Biomet Manufacturing, Inc. | 2001-04-05 | Special | PDF ↗ |
| K003044 | COPELAND RESURFACING HEADS | Biomet, Inc. | 2000-12-13 | Traditional | PDF ↗ |
| K003428 | ISS OFFSET HEADS | Biomet, Inc. | 2000-11-24 | Special | PDF ↗ |
| K001419 | SOLAR SHOULDER OFFSET HUMERAL HEAD | Howmedica Osteonics Corp. | 2000-07-27 | Traditional | PDF ↗ |
| K992525 | ACUMED MODULAR SHOULDER SYSTEM | Acu Med, Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K992394 | BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT | Endotec, Inc. | 1999-10-15 | Traditional | PDF ↗ |
| K984202 | HOWMEDICA HUMERAL INTERCALARY SYSTEM | Howmedica, Inc. | 1999-02-05 | Traditional | PDF ↗ |
| K982886 | OTI MODULAR SHOULDER SYSTEM | Osteoimplant Technology, Inc. | 1998-10-05 | Traditional | PDF ↗ |
| K961260 | KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY | Biomet, Inc. | 1997-04-02 | Traditional | PDF ↗ |
| K962289 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | Intermedics Orthopedics | 1996-08-29 | Traditional | PDF ↗ |
| K954559 | HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM | Howmedica Corp. | 1996-07-12 | Traditional | PDF ↗ |
| K943908 | INFINITY SHOULDER SYSTEM | Wrightmedicaltechnologyinc | 1995-05-30 | Traditional | PDF ↗ |
| K950594 | HEMI-SHOULDER PROSTHESIS | Encore Orthopedics, Inc. | 1995-05-22 | Traditional | PDF ↗ |
| K935593 | ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM | Biodynamic Technologies, Inc. | 1994-10-14 | Traditional | PDF ↗ |
| K913282 | LIMA RPS SHOULDER | Turnkey Intergration USA, Inc. | 1991-10-21 | Traditional | PDF ↗ |
| K911982 | BONE NAIL, KUNTSCHER | International Hospital Supply Co. | 1991-07-26 | Traditional | PDF ↗ |
| K911686 | GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL | Depuy, Inc. | 1991-07-15 | Traditional | PDF ↗ |
| K911902 | TEMPERLITE(TM) SAW BLADE | Sierra Surgical, Inc. | 1991-06-28 | Traditional | PDF ↗ |
| K905577 | EXACTECH HUMERAL SHOULDER PROSTHESIS | Exactech, Inc. | 1991-03-12 | Traditional | PDF ↗ |
| K905580 | TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO | Exactech, Inc. | 1991-03-12 | Traditional | PDF ↗ |
| K874643 | KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS | Kirschner Medical Corp. | 1988-01-06 | Traditional | PDF ↗ |
| K873679 | SELECT SHOULDER SYSTEM | Intermedics Orthopedics | 1987-11-17 | Traditional | PDF ↗ |
| K873073 | KIRSCHNER NEER-III PROXIMAL HUMERUS | Kirschner Medical Corp. | 1987-10-01 | Traditional | PDF ↗ |
| K822771 | 101 NEER TYPE SHOULDER | Intermedics Orthopedics | 1982-10-06 | Traditional | PDF ↗ |
| K802123 | MONOSPHERICAL SHOULDER PROSTHESIS | Howmedica Corp. | 1980-09-16 | Traditional | PDF ↗ |
| K800494 | NEW JERSEY HEMIARTHROPLASTY SHOLDER PROS | Depuy, Inc. | 1980-03-18 | Traditional | PDF ↗ |
| K791548 | REXTON HS(HEARING SYSTEM) | Argosy Intl. (Usa), Inc. | 1979-09-28 | Traditional | PDF ↗ |
Product code HSD · Class II · Orthopedic. Data: openFDA.