FDA Review Panel · OR

FDA 510(k) Orthopedic Devices

FDA 510(k) Orthopedic Devices - Regulatory Overview

FDA 510(k) orthopedic devices include implants, instruments and systems used in musculoskeletal surgery and rehabilitation. The FDA review panel code is OR.

Key categories:

  • Joint replacement implants - hip, knee, shoulder and ankle prostheses
  • Bone fixation systems - plates, screws, nails and external fixators
  • Spinal implants - cages, rods, pedicle screws and disc replacements
  • Surgical navigation - image-guided and robotic-assisted orthopedic surgery
  • Bone grafts and substitutes - synthetic and allograft bone repair materials

With 17,685 submissions, this is one of the largest 510(k) categories. Data sourced from FDA 510(k) public files. Updated monthly.

17985
Total
17965
Cleared
118d
Avg (2y)
1976
Since
17719 Orthopedic devices
12901–12925 of 17719
Cleared Jun 19, 2001
TORNIER TOTAL ELBOW PROSTHESIS
K011567 · Tornier
JDB · Prosthesis, Elbow, Semi-constrained, Cemented · 29d
Cleared Jun 19, 2001
RADIAL HEAD IMPLANT
K011819 · Avanta Orthopaedics, Inc.
KWI · Prosthesis, Elbow, Hemi-, Radial, Polymer · 8d
Cleared Jun 15, 2001
MODIFICATION TO THE BOLD SCREW
K011262 · New Deal, S.A.
HWC · Screw, Fixation, Bone · 51d
Cleared Jun 15, 2001
EXCEL FRACTURE CEMENTED HIP STEM
K011367 · DePuy Orthopaedics, Inc.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 42d
Cleared Jun 15, 2001
OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS
K011622 · Howmedica Osteonics Corp.
HSB · Rod, Fixation, Intramedullary And Accessories · 21d
Cleared Jun 15, 2001
EXETER HIP SYSTEM WITH V40 TAPER
K011623 · Howmedica Osteonics Corp.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 21d
Cleared Jun 13, 2001
MEMODYN STAPLE
K002695 · Telos Medical Equipment
JDR · Staple, Fixation, Bone · 288d
Cleared Jun 13, 2001
PLLA PIN
K010983 · Bionx Implants, Inc.
HTY · Pin, Fixation, Smooth · 72d
Cleared Jun 13, 2001
BARRETT UNICONDYLAR TIBIAL BEARING
K011509 · Biomet, Inc.
HRY · Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer · 28d
Cleared Jun 13, 2001
WORLAND UNICONDYLAR TIBIAL BEARING
K011795 · Biomet, Inc.
HRY · Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer · 5d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION
K010181 · Medtronic Sofamor Danek, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 144d
Cleared Jun 12, 2001
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
K010766 · Synthes (Usa)
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 90d
Cleared Jun 12, 2001
TROCHANTERIC NAIL
K010780 · DePuy Orthopaedics, Inc.
HSB · Rod, Fixation, Intramedullary And Accessories · 89d
Cleared Jun 12, 2001
ISOLA BAND CLAMP
K010972 · Depuyacromed
MNI · Orthosis, Spinal Pedicle Fixation · 71d
Cleared Jun 12, 2001
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
K011007 · Arthrex, Inc.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 69d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM
K011508 · Medtronic Sofamor Danek, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 27d
Cleared Jun 12, 2001
T2 HUMERAL NAIL SYSTEM
K011529 · Howmedica Osteonics Corp.
HSB · Rod, Fixation, Intramedullary And Accessories · 26d
Cleared Jun 06, 2001
USS-LINE EXTENSION
K010108 · Synthes
MNI · Orthosis, Spinal Pedicle Fixation · 145d
Cleared Jun 06, 2001
TBW
K010545 · Tri-Med, Inc.
NDL · Pin, Fixation, Smooth, Metallic · 103d
Cleared Jun 06, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010903 · Endius, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 72d
Cleared Jun 06, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010922 · Endius, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 71d
Cleared Jun 06, 2001
BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
K011390 · Disc-O-Tech Medical Technologies, Ltd.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 30d
Cleared Jun 06, 2001
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
K011437 · Interpore Cross Intl.
MNI · Orthosis, Spinal Pedicle Fixation · 27d
Cleared Jun 05, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011029 · Medtronic Sofamor Danek, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 61d
Cleared Jun 04, 2001
MODIFIED USS FRACTURE SYSTEM
K010658 · Synthes (Usa)
MNI · Orthosis, Spinal Pedicle Fixation · 90d

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All categories 17719 HRS Plate, Fixation, Bone 1323 HWC Screw, Fixation, Bone 1054 JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer 920 NKB Thoracolumbosacral Pedicle Screw System 914 MAX Intervertebral Fusion Device With Bone Graft, Lumbar 897 KWQ Appliance, Fixation, Spinal Intervertebral Body 664 HRX Arthroscope 646 MBI Fastener, Fixation, Nondegradable, Soft Tissue 604 LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented 562 JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented 549 LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented 532 HSB Rod, Fixation, Intramedullary And Accessories 522 MQV Filler, Bone Void, Calcium Compound 493 OLO Orthopedic Stereotaxic Instrument 439 KWP Appliance, Fixation, Spinal Interlaminal 423