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
12926–12950 of 17719
Cleared May 31, 2001
BUTTERFLY PLATE FUNCTION SYSTEM
K010632 · Medtronic Sofamor Danek USA, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 90d
Cleared May 30, 2001
SCAPHIX, STAPLE, FIXATION, BONE
K003033 · Avanta Orthopaedics, Inc.
JDR · Staple, Fixation, Bone · 244d
Cleared May 30, 2001
SYNTHES RESORABLE MESHES AND SHEETS
K003788 · Synthes (Usa)
HRS · Plate, Fixation, Bone · 173d
Cleared May 30, 2001
CONVERGENCE CERVICAL SPINAL SYSTEM
K010639 · Spinal Innovations, LLC
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 86d
Cleared May 30, 2001
2.0/2.4 CANNULATED SCREW SYSTEM
K010783 · Osteomed Corp.
HWC · Screw, Fixation, Bone · 76d
Cleared May 30, 2001
PERC-D SPINEWAND
K010811 · Arthrocare Corp.
HRX · Arthroscope · 72d
Cleared May 29, 2001
SCS CLOSED SCREW
K003733 · Ortho Tec, LLC
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 176d
Cleared May 29, 2001
SYNTHES SYNEX SPACER SYSTEM
K003836 · Synthes
MQP · Spinal Vertebral Body Replacement Device · 168d
Cleared May 29, 2001
DJ ORTHOPEDICS POST SCREW
K010594 · Dj Orthopedics, LLC
HWC · Screw, Fixation, Bone · 90d
Cleared May 25, 2001
MENISCUS ARROW SHEATH #CN1000A
K010554 · Bionx Implants, Inc.
HWC · Screw, Fixation, Bone · 88d
Cleared May 25, 2001
JAX GRANULES BONE VOID FILLER
K010557 · Smith & Nephew, Inc.
MQV · Filler, Bone Void, Calcium Compound · 88d
Cleared May 25, 2001
END-TO-END AND SIDE-BY-SIDE CONNECTORS
K010563 · Spinal Concepts, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 88d
Cleared May 24, 2001
TC-PLUS POROUS FEMORAL COMPONENTS
K011258 · Plus Orthopedics
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 30d
Cleared May 24, 2001
TC-PLUS POROUS TIBIAL COMPONENTS
K011288 · Plus Orthopedics
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 27d
Cleared May 23, 2001
WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014
K003618 · Whiteside Biomechanics, Inc.
NDD · Cerclage, Fixation, Metallic · 182d
Cleared May 23, 2001
SYNTHES ANTEROLATERAL CALCANEAL PLATE
K010518 · Synthes (Usa)
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 90d
Cleared May 23, 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525 · Arthrex, Inc.
HWC · Screw, Fixation, Bone · 90d
Cleared May 23, 2001
MONARCH SPINE SYSTEM
K010576 · Depuyacromed
MNI · Orthosis, Spinal Pedicle Fixation · 85d
Cleared May 23, 2001
LACTOSORB PLATES, MESHES, AND PANELS/SHEETS
K011237 · Biomet, Inc.
HRS · Plate, Fixation, Bone · 30d
Cleared May 18, 2001
ASCENT KNEE SYSTEM
K011219 · Biomet, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 28d
Cleared May 17, 2001
GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM
K010101 · Kinamed, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 126d
Cleared May 17, 2001
EBI DYNAFIX VS OSTEOTOMY SYSTEM
K010551 · Ebi, L.P.
NDF · Plate, Fixation, Bone, Non-spinal, Metallic · 80d
Cleared May 16, 2001
TETHER ACFS
K010466 · Theken Surgical,Llc
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 89d
Cleared May 16, 2001
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
K011182 · Depuyacromed
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 28d
Cleared May 16, 2001
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
K011218 · Exactech, Inc.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 26d

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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