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
117d
Avg (2y)
1976
Since
17609 Orthopedic devices
8226–8250 of 17609
Cleared Sep 28, 2011
SPINEFRONTIER LUMBAR IBF SYSTEM
K111553 · Spinefrontier, Inc.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 117d
Cleared Sep 28, 2011
PIONEER CROSSFUSE II IBF/VBR SYSTEM
K112496 · Pioneer Surgical Technology, Inc.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 30d
Cleared Sep 28, 2011
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
K112556 · Howmedica Osteonics Corp.
MEH · Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate · 26d
Cleared Sep 27, 2011
EXETER HIP STEM
K110290 · Howmedica Osteonics Corp.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 238d
Cleared Sep 27, 2011
META-LOCK SUTURE ANCHOR SYSTEM
K110800 · Tarsus Medical, Inc.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 189d
Cleared Sep 27, 2011
CD HORIZON(R) SPINAL SYSTEM
K112555 · Medtronic Sofamor Danek USA, Inc.
NKB · Thoracolumbosacral Pedicle Screw System · 25d
Cleared Sep 26, 2011
PASS LP SPINAL SYSTEM
K110497 · Medicrea International
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 216d
Cleared Sep 26, 2011
INQU PASTE MIX
K111838 · Isto Technologies, Inc.
MQV · Filler, Bone Void, Calcium Compound · 89d
Cleared Sep 26, 2011
SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
K111880 · Spineology, Inc.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 87d
Cleared Sep 23, 2011
UNITED 36MM CERAMIC FEMORAL HEAD, DELTA
K112463 · United Orthopedic Corporation
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 28d
Cleared Sep 22, 2011
AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES
K112455 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics
HRS · Plate, Fixation, Bone · 28d
Cleared Sep 21, 2011
ODALYS PEDICLE SCREW SYSTEM
K111370 · Kalitec Direct, LLC
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 128d
Cleared Sep 21, 2011
ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD
K111936 · Ortho Development
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 75d
Cleared Sep 20, 2011
Spacer-G and Spacer-K
K101356 · Tecres S.P.A.
KWL · Prosthesis, Hip, Hemi-, Femoral, Metal · 494d
Cleared Sep 16, 2011
TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001
K111629 · Encore Medical, L.P.
PHX · Shoulder Prosthesis, Reverse Configuration · 95d
Cleared Sep 16, 2011
JOURNEY II BCS KNEE SYSTEM
K111711 · Smith & Nephew, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 88d
Cleared Sep 15, 2011
CD HORIZON SPINAL SYSTEM
K111457 · Medtronic Sofamor Danek
NKB · Thoracolumbosacral Pedicle Screw System · 112d
Cleared Sep 15, 2011
CD HORIZON SPINAL SYSTEM
K111510 · Medtronic Sofamor Danek, Inc.
NKB · Thoracolumbosacral Pedicle Screw System · 106d
Cleared Sep 15, 2011
SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM
K112025 · Spinal USA
KWP · Appliance, Fixation, Spinal Interlaminal · 62d
Cleared Sep 13, 2011
MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
K110659 · Medical Concepts, Inc.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 190d
Cleared Sep 13, 2011
CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM
K111115 · Captiva Spine, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 145d
Cleared Sep 12, 2011
DISCOVERY
K111484 · Intuitive Spine, LLC
ODP · Intervertebral Fusion Device With Bone Graft, Cervical · 104d
Cleared Sep 09, 2011
IFS PROFILE PLATES, SCREWS, AND WASHERS
K110086 · Internal Fixation Systems, Inc.
HRS · Plate, Fixation, Bone · 240d
Cleared Sep 09, 2011
ENDOSKELETON(R) TAS
K111626 · Titan Spine, LLC
OVD · Intervertebral Fusion Device With Integrated Fixation, Lumbar · 91d
Cleared Sep 09, 2011
SMITH & NEPHEW RJ CONSTRAINED LINERS
K111635 · Smith & Nephew, Inc.
KWZ · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer · 88d

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All categories 17609 HRS Plate, Fixation, Bone 1319 HWC Screw, Fixation, Bone 1051 JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer 915 NKB Thoracolumbosacral Pedicle Screw System 914 MAX Intervertebral Fusion Device With Bone Graft, Lumbar 897 KWQ Appliance, Fixation, Spinal Intervertebral Body 664 HRX Arthroscope 632 MBI Fastener, Fixation, Nondegradable, Soft Tissue 604 LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented 560 JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented 545 LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented 531 HSB Rod, Fixation, Intramedullary And Accessories 517 MQV Filler, Bone Void, Calcium Compound 493 OLO Orthopedic Stereotaxic Instrument 439 KWP Appliance, Fixation, Spinal Interlaminal 418