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..

1311
Total
1311
Cleared
116d
Avg days
1976
Since
1311 devices
457–480 of 1311
Cleared May 21, 2013
ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM
K131093
Wrightmedicaltechnologyinc
Orthopedic · 33d
Cleared Apr 05, 2013
ARTHREX FRACTURE PLATES
K123241
Arthrex, Inc.
Orthopedic · 170d
Cleared Feb 14, 2013
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM
K123918
Zimmer, Inc.
Orthopedic · 57d
Cleared Jan 25, 2013
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
K123055
Smith & Nephew, Inc.
Orthopedic · 116d
Cleared Oct 12, 2012
ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM
K121651
Wrightmedicaltechnologyinc
Orthopedic · 129d
Cleared Oct 01, 2012
ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM
K121425
Wrightmedicaltechnologyinc
Orthopedic · 140d
Cleared Jul 06, 2012
SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
K121601
Synthes (Usa)
Orthopedic · 35d
Cleared Jun 18, 2012
SYNTHES VA LCP ANKLE TRAUMA SYSTEM
K120854
Synthes (Usa)
Orthopedic · 89d
Cleared May 08, 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
K120717
Synthes (Usa)
Orthopedic · 61d
Cleared May 03, 2012
ORTHOLOC 3DI HALLUX SYSTEM
K120359
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared Apr 04, 2012
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT
K120667
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Apr 02, 2012
ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS
K120802
Wrightmedicaltechnologyinc
Orthopedic · 17d
Cleared Mar 21, 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
K120070
Synthes (Usa)
Orthopedic · 72d
Cleared Jan 31, 2012
CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
K113014
Wrightmedicaltechnologyinc
Orthopedic · 112d
Cleared Dec 12, 2011
ORTHOLOC 3DSI LOCKING SCREWS
K113339
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Nov 14, 2011
PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES
K112406
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Oct 26, 2011
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K112174
Zimmer, Inc.
Orthopedic · 90d
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 02, 2011
ARTHREX DISTAL EXTREMITY PLATE SYSTEM
K111253
Arthrex, Inc.
Orthopedic · 90d
Cleared Jul 21, 2011
EXPLOR RADIAL HEAD PLATING SYSTEM
K110201
Biomet, Inc.
Orthopedic · 178d
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 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