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
17576 Orthopedic devices
5951–5975 of 17576
Cleared Aug 05, 2015
SImmetry Sacroiliac Joint Fusion System
K151818 · Zyga Technology, Inc.
OUR · Sacroiliac Joint Fixation · 30d
Cleared Aug 04, 2015
ForeFoot STP System
K150871 · Tornier, Inc.
HWC · Screw, Fixation, Bone · 125d
Cleared Aug 03, 2015
Metallic Locking Bone Plate and Screw
K142943 · Canwell Medical Co., Ltd.
HRS · Plate, Fixation, Bone · 297d
Cleared Jul 31, 2015
Sniper Spine System
K151813 · Spine Wave, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 29d
Cleared Jul 31, 2015
Biomet Spine Fusion System
K151483 · Biomet Spine, LLC
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 59d
Cleared Jul 29, 2015
LnK Posterior Cervical Fixation System
K143278 · L & K Biomed Co., Ltd.
KWP · Appliance, Fixation, Spinal Interlaminal · 257d
Cleared Jul 28, 2015
Smith and Nephew Legion Hinge Knee System
K151118 · Smith & Nephew
KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer · 92d
Cleared Jul 28, 2015
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa
K151105 · Smith & Nephew, Inc.
MAI · Fastener, Fixation, Biodegradable, Soft Tissue · 95d
Cleared Jul 28, 2015
Piccolo Composite Nailing System
K151010 · CarboFix Orthopedics , Ltd.
HSB · Rod, Fixation, Intramedullary And Accessories · 104d
Cleared Jul 28, 2015
Hyper-C Anterior Cervical Plate System
K150759 · Degen Medical
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 127d
Cleared Jul 28, 2015
2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors
K150715 · Tornier, Inc.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 131d
Cleared Jul 28, 2015
Tyber Medical Wedge System
K150394 · Tyber Medical, LLC
PLF · Bone Wedge · 160d
Cleared Jul 24, 2015
N-Force Fixation System
K151146 · Innovision, Inc.
HWC · Screw, Fixation, Bone · 86d
Cleared Jul 24, 2015
SureLock W Suture Anchor
K151068 · Cayenne Medical, Inc.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 94d
Cleared Jul 23, 2015
KYPHON ELEMENT Inflatable Bone Tamp
K151532 · Medtronic, Inc.
HRX · Arthroscope · 45d
Cleared Jul 23, 2015
CinchLock Flex Knotless Suture Anchor
K151314 · Pivot Medical
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 66d
Cleared Jul 22, 2015
Rampart-T Interbody Fusion System
K151020 · Spineology, Inc.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 97d
Cleared Jul 22, 2015
iFuse Implant System
K150875 · SI-BONE, Inc.
OUR · Sacroiliac Joint Fixation · 112d
Cleared Jul 22, 2015
PATHWAY ELIF
K143143 · Custom Spine, Inc.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 261d
Cleared Jul 20, 2015
Exactech Alteon Monobloc Revision Stem
K150066 · Exactech, Inc.
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 188d
Cleared Jul 17, 2015
PROW FUSION
K151654 · Nlt Spine, Ltd.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 29d
Cleared Jul 17, 2015
A-CIFT SoloFuse
K151198 · Spinefrontier, Inc.
OVE · Intervertebral Fusion Device With Integrated Fixation, Cervical · 73d
Cleared Jul 17, 2015
ProMIS Fixation System
K150380 · Premia Spine, Ltd.
NKB · Thoracolumbosacral Pedicle Screw System · 154d
Cleared Jul 16, 2015
MultiFIX S Knotless Fixation System
K151660 · ArthroCare Corporation
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 27d
Cleared Jul 16, 2015
Refobacin Bone Cement R
K150850 · Biomet, Inc.
MBB · Bone Cement, Antibiotic · 107d

Looking for a specific orthopedic device? Search by device name, K-number or manufacturer.

Search all Orthopedic 510(k) devices

Filter by Product Code

All categories 17576 HRS Plate, Fixation, Bone 1317 HWC Screw, Fixation, Bone 1049 JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer 914 NKB Thoracolumbosacral Pedicle Screw System 914 MAX Intervertebral Fusion Device With Bone Graft, Lumbar 897 KWQ Appliance, Fixation, Spinal Intervertebral Body 663 HRX Arthroscope 626 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 544 LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented 531 HSB Rod, Fixation, Intramedullary And Accessories 514 MQV Filler, Bone Void, Calcium Compound 493 OLO Orthopedic Stereotaxic Instrument 439 KWP Appliance, Fixation, Spinal Interlaminal 416