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
17641 Orthopedic devices
9951–9975 of 17641
Cleared Feb 01, 2008
BONALIVE GRANULES
K071199 · Vivoxid , Ltd.
MQV · Filler, Bone Void, Calcium Compound · 277d
Cleared Jan 31, 2008
ACCIN ANTERIOR CERVICAL PLATE SYSTEM
K073530 · Accelerated Innovation, LLC
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 45d
Cleared Jan 30, 2008
ARDIS SPACER
K073202 · Abbott Spine, Inc.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 78d
Cleared Jan 30, 2008
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K073267 · Endius, Inc.
NKB · Thoracolumbosacral Pedicle Screw System · 71d
Cleared Jan 30, 2008
DEPUY ASR 300 ACETABULAR CUP SYSTEM
K073413 · DePuy Orthopaedics, Inc.
KWA · Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) · 57d
Cleared Jan 29, 2008
SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS
K073135 · Synthes (Usa)
LXT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite · 83d
Cleared Jan 29, 2008
NUVASIVE HELIX MINI ACP SYSTEM
K073275 · Nuvasive, Inc.
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 69d
Cleared Jan 29, 2008
VALEO PEDICLE SCREW SPINAL SYSTEM
K073430 · Amedica Corp.
NKB · Thoracolumbosacral Pedicle Screw System · 54d
Cleared Jan 29, 2008
DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP
K073676 · DePuy Orthopaedics, Inc.
PHX · Shoulder Prosthesis, Reverse Configuration · 32d
Cleared Jan 28, 2008
BUTREX BUTTRESS PLATING SYSTEM
K072943 · X-Spine Systems, Inc.
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 103d
Cleared Jan 28, 2008
ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS
K073233 · Advanced Bio-Surfaces, Inc.
HSH · Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented) · 74d
Cleared Jan 28, 2008
QUANTUM-MIS CANNULATED SYSTEM
K080026 · Pioneer Surgical Technology
MNI · Orthosis, Spinal Pedicle Fixation · 24d
Cleared Jan 28, 2008
MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
K080075 · Elite Surgical Supplies (Pty), Ltd.
MNI · Orthosis, Spinal Pedicle Fixation · 17d
Cleared Jan 25, 2008
BIOSET XCH
K072238 · Regeneration Technologies, Inc.
MQV · Filler, Bone Void, Calcium Compound · 165d
Cleared Jan 25, 2008
STALIF (TM) C
K072415 · Surgicraft , Ltd.
OVE · Intervertebral Fusion Device With Integrated Fixation, Cervical · 150d
Cleared Jan 25, 2008
BENGAL STACKABLE CAGE SYSTEM
K073649 · Depuy Spine, Inc.
MQP · Spinal Vertebral Body Replacement Device · 30d
Cleared Jan 24, 2008
DSS
K072969 · Paradigm Spine, LLC
NQP · Posterior Metal/polymer Spinal System, Fusion · 94d
Cleared Jan 24, 2008
LANX INTERVERTEBRAL BODY FUSION DEVICE
K073144 · Lanx, LLC
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 78d
Cleared Jan 24, 2008
CRYSTAL
K073351 · Spinal Elements, Inc.
ODP · Intervertebral Fusion Device With Bone Graft, Cervical · 56d
Cleared Jan 24, 2008
DEPUY SIGMA PS FEMORAL COMPONENTS
K073529 · DePuy Orthopaedics, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 38d
Cleared Jan 24, 2008
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
K073654 · Blackstone Medical, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 29d
Cleared Jan 24, 2008
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
K080024 · K2m, Inc.
MQP · Spinal Vertebral Body Replacement Device · 20d
Cleared Jan 18, 2008
PATRIOT SPACERS
K072970 · Globus Medical, Inc.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 88d
Cleared Jan 18, 2008
PATRIOT SPACERS: COLONIAL ACDF
K072991 · Globus Medical, Inc.
ODP · Intervertebral Fusion Device With Bone Graft, Cervical · 87d
Cleared Jan 17, 2008
ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT
K071456 · Arthrex, Inc.
MAI · Fastener, Fixation, Biodegradable, Soft Tissue · 237d

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All categories 17641 HRS Plate, Fixation, Bone 1322 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 561 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