HRS · Class II · 21 CFR 888.3030

FDA Product Code HRS: Plate, Fixation, Bone

FDA product code HRS covers bone fixation plates.

These implants stabilize fractures and osteotomies by bridging and compressing bone segments during healing. They are used across skeletal sites including the hand, wrist, foot, and ankle.

HRS devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Synthes (Usa), Wrightmedicaltechnologyinc and Arthrex, Inc..

1319
Total
1319
Cleared
116d
Avg days
1976
Since
1319 devices
553–576 of 1319
Cleared Jan 06, 2012
APTUS WRIST ARTHRODESIS PLATES
K112169
Medartis AG
Orthopedic · 162d
Cleared Dec 23, 2011
STRYKER RESORBABLE FIXATION SYSTEM
K113109
Stryker
Orthopedic · 64d
Cleared Dec 19, 2011
AXSOS LOCKING PLATE SYSTEM
K112926
Stryker Corp.
Orthopedic · 77d
Cleared Dec 15, 2011
APTUS(R) DISTAL HUMERUS SYSTEM
K112560
Medartis AG
Orthopedic · 104d
Cleared Dec 12, 2011
ORTHOLOC 3DSI LOCKING SCREWS
K113339
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Nov 17, 2011
SYNTHES LCP PEDIATRIC PLATE SYSTEMS
K112085
Synthes USA Products, LLC
Orthopedic · 119d
Cleared Nov 14, 2011
PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES
K112406
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Nov 04, 2011
TRIMED CLAVICLE FIXATION SYSTEM
K112509
TriMed, Inc.
Orthopedic · 66d
Cleared Oct 26, 2011
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K112174
Zimmer, Inc.
Orthopedic · 90d
Cleared Oct 06, 2011
EASYLOCK OSTEOSYSTEM
K111266
TriMed, Inc.
Orthopedic · 155d
Cleared Aug 19, 2011
TRIMED RADIOCARPAL FUSION SYSTEM
K102785
TriMed, Inc.
Orthopedic · 326d
Cleared Aug 19, 2011
EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS
K111432
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Aug 08, 2011
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K111540
Synthes (Usa)
Orthopedic · 67d
Cleared Aug 05, 2011
ORTHOPEDIATRICS BLADE PLATE SYSTEM
K110959
OrthoPediatrics Corp.
Orthopedic · 122d
Cleared Aug 02, 2011
ARTHREX DISTAL EXTREMITY PLATE SYSTEM
K111253
Arthrex, Inc.
Orthopedic · 90d
Cleared Jul 22, 2011
MAESTRO WRIST PLATING SYSTEM
K110271
Biomet Manufacturing Corp
Orthopedic · 172d
Cleared Jul 21, 2011
EXPLOR RADIAL HEAD PLATING SYSTEM
K110201
Biomet, Inc.
Orthopedic · 178d
Cleared Jul 21, 2011
COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM
K110320
Biomet Manufacturing Corp
Orthopedic · 168d
Cleared Jul 12, 2011
VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES
K110670
Smith & Nephew, Inc.
Orthopedic · 125d
Cleared Jun 28, 2011
APTUS FOOT 3.5 SYSTEM
K110908
Medartis AG
Orthopedic · 89d
Cleared Jun 17, 2011
ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
K111086
OrthoPediatrics Corp.
Orthopedic · 59d
Cleared May 19, 2011
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
K111039
Zimmer, Inc.
Orthopedic · 35d
Cleared Apr 21, 2011
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
K110125
Synthes (Usa)
Orthopedic · 93d
Cleared Mar 18, 2011
AXSOS (TM) LOCKING PLATE SYSTEM
K110476
Stryker Corp.
Orthopedic · 28d