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
17611 Orthopedic devices
8351–8375 of 17611
Cleared Jul 12, 2011
SOLANAS AVALON POSTERIOR FIXATION SYSTEM
K111076 · Alphatec Spine, Inc.
NKB · Thoracolumbosacral Pedicle Screw System · 85d
Cleared Jul 12, 2011
ORTHOSORB RESORBABLE PINS
K111077 · DePuy Orthopaedics, Inc.
OVZ · Pin, Fixation, Resorbable, Hard Tissue · 85d
Cleared Jul 12, 2011
TITAN TI SUTURE ANCHOR SYSTEM
K111397 · Arthrocare Corp.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 54d
Cleared Jul 06, 2011
REVLOK FENESTRATED SCREW SYSTEM
K110280 · Globus Medical, Inc.
NKB · Thoracolumbosacral Pedicle Screw System · 156d
Cleared Jul 06, 2011
FIGURE 8 STERNOTOMY CLOSURE DEVICE
K110541 · Figure 8 Surgical, Incorporated
JDQ · Cerclage, Fixation · 131d
Cleared Jul 06, 2011
OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM
K111326 · Graham Medical Technologies, LLC
HRS · Plate, Fixation, Bone · 56d
Cleared Jul 06, 2011
PLATEAU SPACER SYSTEM
K111569 · Life Spine
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 30d
Cleared Jul 06, 2011
VIPER SYSTEMS
K111571 · Johnson & Johnson
NKB · Thoracolumbosacral Pedicle Screw System · 30d
Cleared Jul 05, 2011
NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT
K110925 · Novabone Products, LLC
MQV · Filler, Bone Void, Calcium Compound · 95d
Cleared Jul 05, 2011
TOTAL SHOULDER SYSTEM
K111596 · Shoulder Innovations, LLC
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 27d
Cleared Jul 01, 2011
ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
K110940 · Zimmer, Inc.
KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer · 88d
Cleared Jul 01, 2011
TRIGEN LOW PROFILE BONE SCREW
K111025 · Smith & Nephew, Inc.
HSB · Rod, Fixation, Intramedullary And Accessories · 79d
Cleared Jul 01, 2011
U2 HIP SYSTEM
K111546 · United Orthopedic Corp.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 28d
Cleared Jun 30, 2011
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
K103655 · Exactech, Inc.
ODP · Intervertebral Fusion Device With Bone Graft, Cervical · 197d
Cleared Jun 30, 2011
ZYSTON ARC INTERBODY SPACER
K110650 · Biomet Spine (Aka Ebi, LLC)
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 118d
Cleared Jun 29, 2011
CORIN MINIHIP FEMORAL STEM
K111046 · Corin USA
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 75d
Cleared Jun 28, 2011
IVAS 2-10MM (10 GUAGE) BALLON CATHETER
K103807 · Stryker Corporation
NDN · Cement, Bone, Vertebroplasty · 181d
Cleared Jun 28, 2011
APTUS FOOT 3.5 SYSTEM
K110908 · Medartis AG
HRS · Plate, Fixation, Bone · 89d
Cleared Jun 27, 2011
CONSENSUS KNEE SYSTEM
K110950 · Consensus Orthopedics, Inc.
MBH · Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer · 84d
Cleared Jun 27, 2011
APEX ARC HIP STEM
K111193 · Omni Life Science, Inc.
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 60d
Cleared Jun 24, 2011
SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
K110545 · Smith & Nephew, Inc.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 119d
Cleared Jun 22, 2011
ALEUTIAN SPACER SYSTEM
K110843 · K2m, Inc.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 89d
Cleared Jun 22, 2011
APEX PS KNEE SYSTEM - PS-C INSERT
K111184 · Omni Life Science, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 56d
Cleared Jun 22, 2011
UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
K111444 · DePuy Orthopaedics, Inc.
HSB · Rod, Fixation, Intramedullary And Accessories · 29d
Cleared Jun 21, 2011
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
K110805 · Orthofix, Inc.
OBT · Plate, Bone, Growth Control, Pediatric, Epiphysiodesis · 90d

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All categories 17611 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