Panels › Orthopedic › Product code HRS · Class 2
Plate, Fixation, Bone
Regulation 888.3030
64510(k)s in 12 months (1,334 all time)
20recalls in 12 months (288 all time)
277recalls that name a 510(k)
Top companies in HRS
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes | 104 | 8 |
| Smith & Nephew | 37 | 16 |
| Biomet | 21 | 28 |
| Wrightmedicaltechnologyinc | 45 | 0 |
| Zimmer GmbH | 32 | 12 |
| Arthrex, Inc. | 40 | 3 |
| Wright Medical Technology Inc | 0 | 43 |
| DePuy Orthopaedics, Inc. | 18 | 14 |
| Medartis AG | 32 | 0 |
| TriMed, Inc. | 25 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 2012 | K120015 | OSTEOMED WRIST PLATING SYSTEM Osteomed LP | HRS |
| Apr 19, 2012 | K120818 | OTIS-C PLUS Science For Biomaterials, FR | HRS |
| Apr 10, 2012 | K120157 | MINI MAXLOCK EXTREME PLATING SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Apr 4, 2012 | K120667 | VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT Smith & Nephew, Inc. | HRS |
| Apr 2, 2012 | K120802 | ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS Wrightmedicaltechnologyinc | HRS |
| Mar 29, 2012 | K112798 | LOCKING COMPRESSION PLATE SYSTEM Shanghai Microport Orthopedics Co., Ltd., CN | HRS |
| Mar 23, 2012 | K113733 | SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX Neoortho Produtos Ortopedicos S/A | HRS |
| Mar 21, 2012 | K120070 | SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM Synthes USA | HRS |
| Mar 12, 2012 | K112663 | ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL Enhatch Orthopaedics, LLC | HRS |
| Mar 12, 2012 | K111663 | TRAUMA INTERNAL FIXATION SYSTEMS DePuy Orthopaedics, Inc. | HRS |
| Mar 12, 2012 | K110662 | ADAPTIVE WEDGE Adaptive Specialty, LLC | HRS |
| Feb 29, 2012 | K113364 | 2.7MM LCP ULNA OSTEOTOMY SYSTEM Synthes (USA) Products, LLC | HRS |
| Feb 17, 2012 | K120163 | ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM Acute Innovations, LLC | HRS |
| Feb 7, 2012 | K111678 | ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS Ortho Solutions Limited | HRS |
| Feb 6, 2012 | K113762 | CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM Arthrosurface, Inc. | HRS |
| Jan 31, 2012 | K113014 | CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS Wrightmedicaltechnologyinc | HRS |
| Jan 30, 2012 | K113048 | MAXLOCK EXTREME SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Jan 27, 2012 | K113718 | NCB STRAIGHT NARROW SHAFT PLATES Zimmer GmbH | HRS |
| Jan 12, 2012 | K113318 | ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM Acute Innovations, LLC | HRS |
| Jan 11, 2012 | K113405 | SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM Suspension Orthopaedic Solutions, LLC | HRS |
| Jan 6, 2012 | K112169 | APTUS WRIST ARTHRODESIS PLATES Medartis AG | HRS |
| Dec 27, 2011 | K112923 | SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM Suspension Orthopaedic Solutions, LLC | HRS |
| Dec 23, 2011 | K113109 | STRYKER RESORBABLE FIXATION SYSTEM Stryker | HRS |
| Dec 19, 2011 | K112926 | AXSOS LOCKING PLATE SYSTEM Stryker Corp. | HRS |
| Dec 16, 2011 | K112819 | RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW Xiamen Double Engline Medical Material Co., Ltd., CN | HRS |
| Dec 15, 2011 | K112560 | APTUS(R) DISTAL HUMERUS SYSTEM Medartis AG | HRS |
| Dec 12, 2011 | K113339 | ORTHOLOC 3DSI LOCKING SCREWS Wrightmedicaltechnologyinc | HRS |
| Dec 6, 2011 | K110700 | ASCENSION ATLAS HUMERAL PLATING SYSTEM Ascension Orthopedics, Inc. | HRS |
| Nov 17, 2011 | K112085 | SYNTHES LCP PEDIATRIC PLATE SYSTEMS Synthes (USA) Products, LLC | HRS |
| Nov 14, 2011 | K112406 | PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES Smith & Nephew, Inc. | HRS |
| Nov 4, 2011 | K112509 | TRIMED CLAVICLE FIXATION SYSTEM TriMed, Inc. | HRS |
| Oct 26, 2011 | K112689 | SYNTHES STERNAL FIXATION SYSTEM Synthes, Inc. | HRS |
| Oct 26, 2011 | K112174 | NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM Zimmer, Inc. | HRS |
| Oct 24, 2011 | K103513 | LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA Advanced Orthopaedic Solutions, Inc. | HRS |
| Oct 7, 2011 | K111419 | OSTEOMED HAND FUSION SYSTEM Osteomed LP | HRS |
| Oct 6, 2011 | K111266 | EASYLOCK OSTEOSYSTEM TriMed, Inc. | HRS |
| Sep 22, 2011 | K112455 | AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES Howmedica Osteonics Corp., Dba Stryker Orthopaedics | HRS |
| Sep 9, 2011 | K110086 | IFS PROFILE PLATES, SCREWS, AND WASHERS Internal Fixation Systems, Inc. | HRS |
| Aug 23, 2011 | K111620 | SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS Skeletal Dynamics, LLC | HRS |
| Aug 19, 2011 | K111432 | EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS Wrightmedicaltechnologyinc | HRS |
| Aug 19, 2011 | K102785 | TRIMED RADIOCARPAL FUSION SYSTEM TriMed, Inc. | HRS |
| Aug 8, 2011 | K111540 | SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM Synthes (Usa) | HRS |
| Aug 5, 2011 | K110959 | ORTHOPEDIATRICS BLADE PLATE SYSTEM OrthoPediatrics Corp. | HRS |
| Aug 2, 2011 | K111253 | ARTHREX DISTAL EXTREMITY PLATE SYSTEM Arthrex, Inc. | HRS |
| Jul 22, 2011 | K110271 | MAESTRO WRIST PLATING SYSTEM Biomet Manufacturing Corp | HRS |
| Jul 21, 2011 | K110320 | COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM Biomet Manufacturing Corp | HRS |
| Jul 21, 2011 | K110201 | EXPLOR RADIAL HEAD PLATING SYSTEM Biomet, Inc. | HRS |
| Jul 12, 2011 | K110670 | VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES Smith & Nephew, Inc. | HRS |
| Jul 6, 2011 | K111326 | OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM Graham Medical Technologies, LLC | HRS |
| Jun 28, 2011 | K110908 | APTUS FOOT 3.5 SYSTEM Medartis AG | HRS |
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