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
17635 Orthopedic devices
9501–9525 of 17635
Cleared Jan 15, 2009
IMNS MEDACTA NAVIGATION SYSTEM
K083872 · Medacta International S.A.
OLO · Orthopedic Stereotaxic Instrument · 17d
Cleared Jan 14, 2009
EXPANDABLE PEEK-OPTIMA IMPLANT
K082406 · Ebi, L.P.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 146d
Cleared Jan 14, 2009
SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM
K083025 · Synthes (Usa)
HRS · Plate, Fixation, Bone · 96d
Cleared Jan 13, 2009
TRAUSON INTRAMEDULLARY NAIL
K081230 · Trauson (Jiangsu) Medical Instrument Co., Ltd.
HSB · Rod, Fixation, Intramedullary And Accessories · 258d
Cleared Jan 13, 2009
NEWPORT SPINAL SYSTEM
K083089 · Seaspine, Inc.
NKB · Thoracolumbosacral Pedicle Screw System · 89d
Cleared Jan 13, 2009
PHENIX CERVICAL INTERBODY DEVICE
K083167 · Spinal Devices, LLC
ODP · Intervertebral Fusion Device With Bone Graft, Cervical · 78d
Cleared Jan 13, 2009
CAPSURE PS SYSTEM
K083743 · Spine Wave, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 28d
Cleared Jan 12, 2009
ASCENSION SILICONE PIP
K082231 · Ascension Orthopedics, Inc.
KYJ · Prosthesis, Finger, Constrained, Polymer · 158d
Cleared Jan 12, 2009
OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES
K083240 · Arthrocare Corp.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 70d
Cleared Jan 09, 2009
XYCOR SPINAL IMPLANT
K082466 · Vertebration,Inc
MQP · Spinal Vertebral Body Replacement Device · 135d
Cleared Jan 09, 2009
REVOLVE STABILIZATION SYSTEM
K083416 · Globus Medical, Inc.
NKB · Thoracolumbosacral Pedicle Screw System · 52d
Cleared Jan 07, 2009
PERI-LOC BONE PLATING AND SCREW SYSTEM
K083032 · Smith & Nephew, Inc.
HRS · Plate, Fixation, Bone · 89d
Cleared Jan 02, 2009
THEKEN SPINE VU EPOD AND VU LPOD SYSTEM
K082712 · Theken Spine, LLC
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 108d
Cleared Dec 30, 2008
ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART
K082999 · Arthrex, Inc.
MAI · Fastener, Fixation, Biodegradable, Soft Tissue · 83d
Cleared Dec 30, 2008
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
K083213 · Synthes (Usa)
HRS · Plate, Fixation, Bone · 60d
Cleared Dec 29, 2008
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS
K082792 · Medacta International S.A.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 97d
Cleared Dec 29, 2008
REJUVENATE MONOLITHIC HIP SYSTEM
K082892 · Howmedica Osteonics Corp.
MEH · Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate · 90d
Cleared Dec 29, 2008
CLYDESDALE SPINAL SYSTEM
K083026 · Medtronic Sofamor Danek
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 80d
Cleared Dec 24, 2008
MODIFICATION TO:MICROFUSE BONE VOID FILLER
K083232 · Globus Medical, Inc.
MQV · Filler, Bone Void, Calcium Compound · 51d
Cleared Dec 22, 2008
PHANTOM PLUS CAGE SYSTEM
K082801 · Us Spine
ODP · Intervertebral Fusion Device With Bone Graft, Cervical · 89d
Cleared Dec 22, 2008
ZUMA, MODEL 55-XXXX/56-XXXX
K082926 · Seaspine, Inc.
OVD · Intervertebral Fusion Device With Integrated Fixation, Lumbar · 82d
Cleared Dec 19, 2008
PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)
K081608 · Toby Orthopaedics, LLC
HRS · Plate, Fixation, Bone · 193d
Cleared Dec 19, 2008
RIMCLOSE BONE ANCHOR
K082729 · Anulex Technologies, Inc.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 92d
Cleared Dec 18, 2008
REGEN COLLAGEN SCAFFOLD (CS)
K082079 · Regen Biologics, Inc.
OLC · Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen · 148d
Cleared Dec 18, 2008
ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS
K082527 · Zimmer, Inc.
HRS · Plate, Fixation, Bone · 107d

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All categories 17635 HRS Plate, Fixation, Bone 1321 HWC Screw, Fixation, Bone 1052 JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer 919 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 546 LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented 532 HSB Rod, Fixation, Intramedullary And Accessories 518 MQV Filler, Bone Void, Calcium Compound 493 OLO Orthopedic Stereotaxic Instrument 439 KWP Appliance, Fixation, Spinal Interlaminal 421