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
17610 Orthopedic devices
8326–8350 of 17610
Cleared Jul 21, 2011
ETURN SPINAL IMPLANT MODEL ETURN XX-12
K100305 · Icotec
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 533d
Cleared Jul 21, 2011
DSC/ALF SPINAL SYSTEM
K101886 · Sintea Plastek, LLC
MQP · Spinal Vertebral Body Replacement Device · 380d
Cleared Jul 21, 2011
COREN TOTAL HIP SYSTEM
K103431 · Corentec Co., Ltd.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 240d
Cleared Jul 21, 2011
GENESYS SPINE TILOCK SYSTEM
K103671 · Genesys Spine
NKB · Thoracolumbosacral Pedicle Screw System · 217d
Cleared Jul 21, 2011
DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809
K103831 · Depuy Mitek, A Johnson & Johnson Company
MAI · Fastener, Fixation, Biodegradable, Soft Tissue · 203d
Cleared Jul 21, 2011
EXPLOR RADIAL HEAD PLATING SYSTEM
K110201 · Biomet, Inc.
HRS · Plate, Fixation, Bone · 178d
Cleared Jul 21, 2011
COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM
K110320 · Biomet Manufacturing Corp
HRS · Plate, Fixation, Bone · 168d
Cleared Jul 21, 2011
REXIOUS SPINAL FIXATION SYSTEM
K111362 · Dio Medical Co., Ltd.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 66d
Cleared Jul 21, 2011
METASURG DIGIFUSE IMPLANT
K111536 · Metasurg
HWC · Screw, Fixation, Bone · 49d
Cleared Jul 21, 2011
SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM
K111801 · Zyga Technology, Inc.
OUR · Sacroiliac Joint Fixation · 24d
Cleared Jul 20, 2011
HEMI IMPLANT
K102401 · Vilex, Inc.
KWD · Prosthesis, Toe, Hemi-, Phalangeal · 330d
Cleared Jul 20, 2011
REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)
K111061 · Encore Medical, L.P.
PHX · Shoulder Prosthesis, Reverse Configuration · 93d
Cleared Jul 20, 2011
AAP CANNULATED SCREWS
K111316 · Aap Implantate AG
HWC · Screw, Fixation, Bone · 71d
Cleared Jul 20, 2011
SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75
K111399 · Arthrocare Corp.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 62d
Cleared Jul 20, 2011
PATHWAY MODEL 07XXXX
K111774 · Custom Spine
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 27d
Cleared Jul 19, 2011
STAXXSD SYSTEM
K111469 · Spine Wave, Inc.
MQP · Spinal Vertebral Body Replacement Device · 53d
Cleared Jul 19, 2011
PLATEAU SPACER SYSTEM
K111835 · Life Spine, Inc.
ODP · Intervertebral Fusion Device With Bone Graft, Cervical · 20d
Cleared Jul 18, 2011
CAPSTONE R SPINAL SYSTEM
K103731 · Medtronic Sofamor Danek
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 208d
Cleared Jul 15, 2011
EXACTECH GIBRALT SPINAL SYSTEM
K110197 · Exactech, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 172d
Cleared Jul 15, 2011
SMR SHOULDER SYSTEM - CTA HUMERAL HEADS
K110847 · Lima Corporate S.P.A.
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 109d
Cleared Jul 13, 2011
ATLAS SPINE PEDICLE SCREW SYSTEM
K110842 · Atlas Spine, Inc.
NKB · Thoracolumbosacral Pedicle Screw System · 110d
Cleared Jul 13, 2011
APEX KNEE SYSTEM, APEX ALL POLY TIBIA
K111062 · Omni Life Science, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 86d
Cleared Jul 12, 2011
ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K101997 · Ellipse Technologies, Inc.
HSB · Rod, Fixation, Intramedullary And Accessories · 362d
Cleared Jul 12, 2011
PRO FIXATION SYSTEM
K110538 · Synovis Orthopedic & Woundcare
HWC · Screw, Fixation, Bone · 137d
Cleared Jul 12, 2011
VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES
K110670 · Smith & Nephew, Inc.
HRS · Plate, Fixation, Bone · 125d

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All categories 17610 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