OrthoPediatrics Corp

FDA Regulatory Profile

Summary

Total Recalls
26
510(k) Clearances
43
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0277-2023Class IIOrthex Large Bone Shoulder Bolt, model no. AS-17September 12, 2022
Z-1678-2022Class IIOrthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BNJune 29, 2022
Z-2742-2020Class IIOrthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intendedJuly 6, 2020
Z-2539-2020Class IIOrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 June 5, 2020
Z-2538-2020Class IIOrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 June 5, 2020
Z-0125-2020Class IIOrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targetingAugust 19, 2019
Z-0218-2020Class IIModel No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. PrAugust 19, 2019
Z-0219-2020Class IIModel No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing PlatforAugust 19, 2019
Z-0597-2018Class IIResponse 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervicaAugust 3, 2017
Z-2321-2017Class IIResponse BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilizedApril 24, 2017
Z-0879-2017Class IIIOrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical ScrewNovember 18, 2016
Z-2844-2016Class II3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System July 27, 2016
Z-2843-2016Class II3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System July 27, 2016
Z-0622-2016Class IIUniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is inNovember 10, 2015
Z-2796-2015Class II3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mJuly 28, 2015
Z-2560-2014Class IIACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm ProductJuly 25, 2014
Z-0934-2014Class II3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPJanuary 8, 2014
Z-0579-2014Class IIOrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction November 7, 2013
Z-0276-2014Class II3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating September 26, 2013
Z-1941-2013Class II3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill aJuly 24, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K252600Pediatric Plating Platform I Small-MiniOctober 9, 2025
K251362PediFlex™ Flexible Nail SystemJune 24, 2025
K243963Pediatric Plating Platform HipApril 29, 2025
K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurApril 1, 2025
K241816VerteGlide Spinal Growth Guidance SystemMarch 14, 2025
K243798Orthex External Fixation SystemMarch 7, 2025
K233105RESPONSE™ Rib and Pelvic SystemJanuary 20, 2024
K231266Pediatric Nailing Platform TibiaAugust 21, 2023
K222105RESPONSE 5.5/6.0 Cannulated Screw SystemMarch 23, 2023
K223786Orthex External Fixation SystemFebruary 10, 2023
K220679Pediatric Nailing Platform FemurJuly 20, 2022
K220809Drive Rail SystemApril 8, 2022
K203573RESPONSE Navigation InstrumentsFebruary 4, 2021
K201838PediFlex Flexible Nail SystemJanuary 29, 2021
K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemMarch 24, 2020
K200097Response BandLoc Spinal FixationMarch 16, 2020
K190321Pediatric Nailing PlatformFemurOctober 9, 2019
K190992OrthoPediatrics PediFoot Deformity Corrections SystemAugust 6, 2019
K190324OrthoPediatrics Cannulated Screw SystemJuly 5, 2019
K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemSeptember 18, 2018