Medical Device Manufacturer · US , Warsaw , IN

OrthoPediatrics Corp.

39 submissions · 37 cleared · Since 2008
39
Total
37
Cleared
0
Denied

OrthoPediatrics Corp. — FDA 510(k) Submissions

OrthoPediatrics Corp. has submitted 39 FDA 510(k) premarket notifications since 2008, of which 37 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plate, Fixation, Bone, Rod, Fixation, Intramedullary And Accessories, Thoracolumbosacral Pedicle Screw System, Pin, Fixation, Smooth, Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis . Use the specialty filter in the sidebar to narrow results.

39 devices
1–25 of 39
Pediatric Plating Platform I Small-Mini
K252600 · HRS Plate, Fixation, Bone · Orthopedic
Oct 2025 52d
PediFlex? Flexible Nail System
K251362 · HTY Pin, Fixation, Smooth · Orthopedic
Jun 2025 54d
Pediatric Plating Platform Hip
K243963 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2025 127d
Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur
K250623 · HSB Rod, Fixation,... · Orthopedic
Apr 2025 29d
VerteGlide Spinal Growth Guidance System
K241816 · PGM Growing Rod System · Orthopedic
Mar 2025 263d
Orthex External Fixation System
K243798 · KTT Appliance, Fixation,... · Orthopedic
Mar 2025 86d
RESPONSE? Rib and Pelvic System
K233105 · MDI Prosthesis, Rib Replacement · Orthopedic
Jan 2024 115d
Pediatric Nailing Platform Tibia
K231266 · HSB Rod, Fixation,... · Orthopedic
Aug 2023 111d
RESPONSE 5.5/6.0 Cannulated Screw System
K222105 · NKB Thoracolumbosacral... · Orthopedic
Mar 2023 248d
Orthex External Fixation System
K223786 · KTT Appliance, Fixation,... · Orthopedic
Feb 2023 53d
Pediatric Nailing Platform Femur
K220679 · HSB Rod, Fixation,... · Orthopedic
Jul 2022 134d
Drive Rail System
K220809 · KTT Appliance, Fixation,... · Orthopedic
Apr 2022 18d
RESPONSE Navigation Instruments
K203573 · OLO Orthopedic Stereotaxic... · Orthopedic
Feb 2021 59d
PediFlex Flexible Nail System
K201838 · HTY Pin, Fixation, Smooth · Orthopedic
Jan 2021 211d
RESPONSE? Spine System, RESPONSE? 4.5/5.0 Spine System, RESPONSE? 5.5/6.0 Spine System
K193100 · NKB Thoracolumbosacral... · Orthopedic
Mar 2020 137d
Response BandLoc Spinal Fixation
K200097 · OWI Bone Fixation Cerclage,... · Orthopedic
Mar 2020 60d
Pediatric Nailing PlatformFemur
K190321 · HSB Rod, Fixation,... · Orthopedic
Oct 2019 238d
OrthoPediatrics PediFoot Deformity Corrections System
K190992 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2019 113d
OrthoPediatrics Cannulated Screw System
K190324 · HWC Screw, Fixation, Bone · Orthopedic
Jul 2019 142d
Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
K181390 · NKB Thoracolumbosacral... · Orthopedic
Sep 2018 112d
OrthoPediatrics Titanium PediPlates? System
K171173 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2017 125d
OrthoPediatrics Locking Proximal Femur System Cortical Screws
K162307 · HRS Plate, Fixation, Bone · Orthopedic
Sep 2016 41d
Response BandLoc Spinal Fixation
K161267 · OWI Bone Fixation Cerclage,... · Orthopedic
Aug 2016 98d
Response 5.5 Spine System
K160466 · NKB Thoracolumbosacral... · Orthopedic
Mar 2016 33d
Response 5.5/6.0 Spine System
K150600 · NKB Thoracolumbosacral... · Orthopedic
May 2015 73d
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