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
8126–8150 of 17609
Cleared Dec 05, 2011
AXLE PEEK INTERSPINOUS FUSION SYSTEM
K112592 · X-Spine Systems, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 89d
Cleared Dec 02, 2011
APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
K112779 · Omnlife Science
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 67d
Cleared Dec 01, 2011
ACCULIF TL-PEEK IBF CAGE
K112095 · Coalign Innovations, Inc.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 132d
Cleared Dec 01, 2011
LATERAL BUTTON
K112296 · T.A.G. Medical Products Corporation, Ltd.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 114d
Cleared Nov 30, 2011
ALAMO C
K112361 · Alliance Partners, LLC
ODP · Intervertebral Fusion Device With Bone Graft, Cervical · 105d
Cleared Nov 29, 2011
RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
K111272 · Rhausler, Inc.
OVE · Intervertebral Fusion Device With Integrated Fixation, Cervical · 209d
Cleared Nov 29, 2011
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
K111908 · Biomet Microfixation, Inc.
HWC · Screw, Fixation, Bone · 147d
Cleared Nov 28, 2011
RAPTOR FACET FIXATION SYSTEM
K110170 · Alphatec Spine, Inc.
MRW · System, Facet Screw Spinal Device · 312d
Cleared Nov 28, 2011
SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
K111891 · Synthes USA Products, LLC
HSB · Rod, Fixation, Intramedullary And Accessories · 146d
Cleared Nov 23, 2011
TRABECULAR METAL (TM) FUSION DEVICE
K111119 · Zimmer Spine, Inc.
ODP · Intervertebral Fusion Device With Bone Graft, Cervical · 216d
Cleared Nov 23, 2011
PROFEMUR GLADIATOR HA HIP STEM
K112150 · Wrightmedicaltechnologyinc
KWA · Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) · 119d
Cleared Nov 22, 2011
DEVINE SPINAL SYSTEM
K111690 · Changzhou Orthmed Medical Instrument Co., Ltd.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 159d
Cleared Nov 22, 2011
NB3D BONE VOID FILLER
K111944 · Pioneer Surgical Technology, Inc.
MQV · Filler, Bone Void, Calcium Compound · 137d
Cleared Nov 22, 2011
ZAVATION SPINAL SYSTEM
K112484 · Zavation, LLC
MNI · Orthosis, Spinal Pedicle Fixation · 85d
Cleared Nov 21, 2011
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · Exactech, Inc.
MRW · System, Facet Screw Spinal Device · 122d
Cleared Nov 21, 2011
CLYDESDALES SPINAL SYSTEM
K112405 · Medtronic Sofamor Danek USA, Inc.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 91d
Cleared Nov 21, 2011
PASS LP SPINAL SYSTEM
K112493 · Medicrea International
MNI · Orthosis, Spinal Pedicle Fixation · 84d
Cleared Nov 21, 2011
S4 SPINAL SYSTEM
K112551 · Aesculap Implant System, Inc.
NKB · Thoracolumbosacral Pedicle Screw System · 81d
Cleared Nov 21, 2011
DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
K112724 · Medos International SARL
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 63d
Cleared Nov 21, 2011
CD HORIZON SPINAL SYSTEM
K113174 · Medtronic Sofamor Danek USA, Inc.
NKB · Thoracolumbosacral Pedicle Screw System · 25d
Cleared Nov 18, 2011
SYNTHES USS
K111358 · Synthes Spine
NKB · Thoracolumbosacral Pedicle Screw System · 186d
Cleared Nov 18, 2011
GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
K111593 · Bm Korea Co., Ltd.
NDN · Cement, Bone, Vertebroplasty · 164d
Cleared Nov 18, 2011
VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX
K111983 · Zimmer Trabecular Metal Technology
ODP · Intervertebral Fusion Device With Bone Graft, Cervical · 129d
Cleared Nov 17, 2011
SYNTHES LCP PEDIATRIC PLATE SYSTEMS
K112085 · Synthes USA Products, LLC
HRS · Plate, Fixation, Bone · 119d
Cleared Nov 17, 2011
MEMOMETAL INTRA-MEDULLARY BONE FASTENER
K112197 · Memometal Technologies
HTY · Pin, Fixation, Smooth · 108d

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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