FDA Product Code
FDA Product Code PHX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3660
510(k) Clearances — 206 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K181611 | Comprehensive Reverse Shoulder System | Biomet Manufacturing Corp | 2018-09-24 | Traditional | PDF ↗ |
| K180632 | Exactech Equinoxe Small Reverse Shoulder System | Exactech, Inc. | 2018-07-25 | Special | PDF ↗ |
| K173717 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2018-06-21 | Special | PDF ↗ |
| K173900 | Arthrex Univers Revers Modular Glenoid System | Arthrex, Inc. | 2018-04-20 | Traditional | PDF ↗ |
| K180089 | Medacta Shoulder System Short Humeral Diaphysis | Medacta International S.A. | 2018-04-05 | Traditional | PDF ↗ |
| K172371 | Arthrex UNIVERS REVERS COATED BASEPLATE | Arthrex, Inc. | 2018-03-22 | Traditional | PDF ↗ |
| K173411 | Comprehensive Segmental Revision System (SRS) | Biomet Manufacturing Corp | 2018-02-08 | Traditional | PDF ↗ |
| K171789 | ARROW Reverse Porous Glenoid | Fournitures Hospitalieres Industrie | 2018-01-23 | Traditional | PDF ↗ |
| K170748 | GLOBAL UNITE Platform Shoulder System | Depuy Ireland UC | 2018-01-11 | Traditional | PDF ↗ |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate | Biomet Manufacturing Corp | 2018-01-03 | Traditional | PDF ↗ |
| K173073 | AltiVate Anatomic to Reverse Conversion Module | Encore Medical L.P. | 2017-12-26 | Traditional | PDF ↗ |
| K170414 | Arthrex Univers Revers Apex Humeral Stems | Arthrex, Inc. | 2017-12-14 | Traditional | PDF ↗ |
| K171058 | Medacta Shoulder System: Threaded Glenoid Baseplate | Medacta International S.A. | 2017-12-13 | Traditional | PDF ↗ |
| K172767 | Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid | Zimmer, Inc. | 2017-11-30 | Traditional | PDF ↗ |
| K170452 | Medacta Shoulder System | Medacta International S.A. | 2017-10-05 | Traditional | PDF ↗ |
| K170711 | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System | Zimmer GmbH | 2017-06-01 | Traditional | PDF ↗ |
| K163669 | Humeris Shoulder | Fx Solutions | 2017-05-17 | Traditional | PDF ↗ |
| K162325 | Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw | Exactech, Inc. | 2017-03-06 | Special | PDF ↗ |
| K161120 | SMR TT Metal Back Glenoid, Bone Graft instruments | Lima Corporate S.P.A. | 2017-02-21 | Traditional | PDF ↗ |
| K162726 | Exactech® Equinoxe® Preserve Stem | Exactech, Inc. | 2017-02-01 | Traditional | PDF ↗ |
| K162455 | Humelock Reversed Shoulder | Fx Solutions | 2017-01-17 | Traditional | PDF ↗ |
| K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | Tornier, Inc. | 2016-11-15 | Traditional | PDF ↗ |
| K161189 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2016-08-25 | Traditional | PDF ↗ |
| K152754 | COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) | Biomet Manufacturing Corp | 2016-05-16 | Traditional | PDF ↗ |
| K152966 | Aequalis Fx2 | Tornier S.A.S. | 2016-01-14 | Special | PDF ↗ |
| K150488 | Humelock II Reversible Shoulder System | Fx Solutions | 2015-11-13 | Traditional | PDF ↗ |
| K150568 | ARROW Humeral stems size 6 and 16 | Fournitures Hospitalieres Industrie | 2015-10-29 | Traditional | PDF ↗ |
| K150458 | Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere | Exactech, Inc. | 2015-05-14 | Special | PDF ↗ |
| K142778 | ARROW Reverse Shoulder long keel and short keel glenoid base | Fournitures Hospitalieres Industrie | 2015-03-20 | Traditional | PDF ↗ |
| K142863 | Univers Rivers Shoulder Prosthesis System | Arthrex, Inc. | 2014-11-25 | Traditional | PDF ↗ |
| K141345 | AEQUALIS FX2 | Tornier S.A.S. | 2014-11-18 | Traditional | PDF ↗ |
| K141990 | ENCORE HUMERAL SHOULDER STEM | Encore Medical L.P. | 2014-11-07 | Traditional | PDF ↗ |
| K142139 | SMR 40MM GLENOSPHERE | Lima Corporate S.P.A. | 2014-11-07 | Traditional | PDF ↗ |
| K140478 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Tornier S.A.S. | 2014-08-06 | Traditional | PDF ↗ |
| K140082 | AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM | Tornier S.A.S. | 2014-07-18 | Traditional | PDF ↗ |
| K140652 | POROUS COATED COMPREHENSIVE FRACTURE STEMS | Biomet Manufacturing Corp | 2014-07-03 | Traditional | PDF ↗ |
| K141029 | TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM | Tornier, Inc. | 2014-06-18 | Special | PDF ↗ |
| K141006 | RSP HUMERAL SOCKET INSERT | Djo Global | 2014-06-05 | Special | PDF ↗ |
| K133378 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM | Zimmer, Inc. | 2014-05-12 | Traditional | PDF ↗ |
| K140904 | RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6 | Encore Medical L.P. | 2014-05-06 | Special | PDF ↗ |
| K130550 | RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW | Encore Medical L.P. | 2014-03-24 | Traditional | PDF ↗ |
| K130895 | REUNION RSA SHOULDER SYSTEM | Howmedica Osteonics Corp. | 2013-12-27 | Traditional | PDF ↗ |
| K132285 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Tornier S.A.S. | 2013-12-05 | Traditional | PDF ↗ |
| K131231 | AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS | Tornier S.A.S. | 2013-10-16 | Traditional | PDF ↗ |
| K130390 | COMPREHENSIVE CONVERTIBLE GLENOID | Biomet Manufacturing, Inc. | 2013-10-09 | Traditional | PDF ↗ |
| K131353 | COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE | Biomet Manufacturing Corp | 2013-10-08 | Traditional | PDF ↗ |
| K132239 | COMPREHENSIVE REVERSE SHOULDER SCREWS | Biomet Manufacturing Corp | 2013-09-06 | Traditional | PDF ↗ |
| K131575 | EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT | Exactech, Inc. | 2013-07-03 | Special | PDF ↗ |
| K130661 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM | Zimmer, Inc. | 2013-05-09 | Traditional | PDF ↗ |
| K121067 | EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE | Exactech, Inc. | 2012-12-06 | Special | PDF ↗ |
| K122692 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS | Zimmer, Inc. | 2012-12-03 | Traditional | PDF ↗ |
| K122442 | DEPUY CTA REVERSE SHOULDER SYSTEM | Depuy France | 2012-09-06 | Special | PDF ↗ |
| K121183 | COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS | Biomet Corporation | 2012-07-26 | Traditional | PDF ↗ |
| K112193 | ARROW REVERSE SHOULDER SYSTEM | Fournitures Hospitalieres Industrie | 2012-07-12 | Traditional | PDF ↗ |
| K120374 | SEVIIN REVERSE SHOULDER | Ingen Orthopedics, LLC | 2012-07-09 | Traditional | PDF ↗ |
| K120739 | AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM | Tornier, Inc. | 2012-07-05 | Traditional | PDF ↗ |
| K120174 | DEPUT DELTA XTEND REVERSE SHOULDER | Depuy France | 2012-06-11 | Traditional | PDF ↗ |
| K112144 | AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS | Tornier | 2012-03-13 | Special | PDF ↗ |
| K113254 | SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS | Lima Corporate S.P.A. | 2012-02-24 | Traditional | PDF ↗ |
| K120121 | COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE | Biomet, Inc. | 2012-02-16 | Special | PDF ↗ |
| K113069 | COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY | Biomet Manufacturing Corp | 2012-01-11 | Traditional | PDF ↗ |
| K113523 | LIMACORPORATE SMR REVERSE SHOULDER SYSTEM | Lima Corporate S.P.A. | 2011-12-20 | Special | PDF ↗ |
| K113121 | COMPREHENSIVE REVERSE SHOULDER | Biomet Manufacturing, Inc. | 2011-12-16 | Special | PDF ↗ |
| K112069 | RSP GLENOID BASEPLATE POROUS COATED | Encore Medical L.P. | 2011-11-15 | Traditional | PDF ↗ |
| K103251 | DUOCENTRIC REVERSED | Aston Medical | 2011-10-28 | Traditional | PDF ↗ |
| K112615 | AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM | Tornier, Inc. | 2011-10-11 | Special | PDF ↗ |
| K111735 | REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER | Encore Medical L.P. | 2011-10-03 | Traditional | PDF ↗ |
| K111629 | TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 | Encore Medical L.P. | 2011-09-16 | Traditional | PDF ↗ |
| K110598 | SMR REVERSE SHOULDER SYSTEM | Lima Corporate S.P.A. | 2011-08-18 | Traditional | PDF ↗ |
| K111061 | REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) | Encore Medical L.P. | 2011-07-20 | Special | PDF ↗ |
| K110599 | AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM | Tornier, Inc. | 2011-06-14 | Traditional | PDF ↗ |
| K110708 | EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... | Exactech, Inc. | 2011-04-01 | Special | PDF ↗ |
| K103208 | REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM | Encore Medical L.P. | 2011-01-31 | Traditional | PDF ↗ |
| K101996 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | Depuy(Ireland) | 2010-12-15 | Traditional | PDF ↗ |
| K102951 | EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) | Exactech, Inc. | 2010-11-04 | Special | PDF ↗ |
| K093803 | BIO-MODULAR REVERSE SHOLDER | Biomet Manufacturing Corp | 2010-10-19 | Traditional | PDF ↗ |
| K100741 | REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 | Encore Medical L.P. | 2010-08-02 | Special | PDF ↗ |
| K101909 | EXACTECH EQUINOXE, PLATFORM FRACTURE STEM | Exactech, Inc. | 2010-08-02 | Special | PDF ↗ |
| K093275 | EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER | Exactech, Inc. | 2010-05-27 | Special | PDF ↗ |
| K100142 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Tornier | 2010-05-06 | Traditional | PDF ↗ |
| K092900 | EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM | Exactech, Inc. | 2010-01-07 | Traditional | PDF ↗ |
| K092873 | REVERSE SHOULDER PROSTHESIS | Djo Surgical | 2009-10-27 | Special | PDF ↗ |
| K082702 | EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY | Exactech, Inc. | 2008-10-10 | Special | PDF ↗ |
| K081016 | SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM | Smith & Nephew, Inc. | 2008-09-05 | Traditional | PDF ↗ |
| K081059 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Tornier | 2008-07-17 | Special | PDF ↗ |
| K080642 | COMPREHENSIVE REVERSE SHOULDER | Biomet, Inc. | 2008-07-09 | Traditional | PDF ↗ |
| K073688 | EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW | Exactech, Inc. | 2008-02-29 | Special | PDF ↗ |
| K073676 | DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP | DePuy Orthopaedics, Inc. | 2008-01-29 | Special | PDF ↗ |
| K072804 | COMPREHENSIVE RS SHOULDER SYSTEM | Biomet Manufacturing Corp | 2007-12-12 | Traditional | PDF ↗ |
| K071948 | AEQUALIS REVERSED ADAPTER | Tornier | 2007-10-18 | Traditional | PDF ↗ |
| K071379 | DELTA XTEND REVERSE SHOULDER MODULAR STEM | DePuy Orthopaedics, Inc. | 2007-09-11 | Traditional | PDF ↗ |
| K063569 | EQUINOXE REVERSE SHOULDER SYSTEM | Exactech, Inc. | 2007-02-23 | Traditional | PDF ↗ |
| K062250 | DELTA XTEND REVERSE SHOULDER SYSTEM | DePuy Orthopaedics, Inc. | 2007-02-02 | Traditional | PDF ↗ |
| K062116 | DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS | DePuy Orthopaedics, Inc. | 2006-08-18 | Special | PDF ↗ |
| K061439 | AEQUALIS REVERSED PROSTHESIS | Tornier | 2006-07-20 | Special | PDF ↗ |
| K060704 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM | Zimmer, Inc. | 2006-05-19 | Special | PDF ↗ |
| K053274 | ANATOMICAL SHOULDER INVERSE/REVERSE | Zimmer GmbH | 2006-01-25 | Traditional | PDF ↗ |
| K052906 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM | Zimmer, Inc. | 2005-12-19 | Traditional | PDF ↗ |
| K052086 | ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER | Encore Medical, Inc. | 2005-08-31 | Special | PDF ↗ |
| K051075 | ENCORE REVERSE SHOULDER PROSTHESIS | Encore Medical L.P. | 2005-05-27 | Special | PDF ↗ |
Product code PHX · Class II · Orthopedic. Data: openFDA.