Company · US
OrthoPediatrics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (2 in 12 months)
52recalls (0 in 12 months)
49recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 38 |
| HRS | Plate, Fixation, Bone | 19 |
| HWC | Screw, Fixation, Bone | 9 |
| NKB | Thoracolumbosacral Pedicle Screw System | 7 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 5 |
| HTY | Pin, Fixation, Smooth | 4 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 4 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | 4 |
| OWI | Bone Fixation Cerclage, Sublaminar | 3 |
| MDI | Prosthesis, Rib Replacement | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 |
| OSN | Software For Diagnosis/Treatment | 1 |
| PGM | Growing Rod System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2026 | K261345 | Pediatric Nailing Platform Femur OrthoPediatrics Corp. | HSB |
| Apr 30, 2026 | K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System OrthoPediatrics Corp. | HRS |
| Oct 9, 2025 | K252600 | Pediatric Plating Platform I Small-Mini OrthoPediatrics Corp. | HRS |
| Jun 24, 2025 | K251362 | PediFlex Flexible Nail System OrthoPediatrics Corp. | HTY |
| Apr 29, 2025 | K243963 | Pediatric Plating Platform Hip OrthoPediatrics Corp. | HRS |
| Apr 1, 2025 | K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur OrthoPediatrics Corp. | HSB |
| Mar 14, 2025 | K241816 | VerteGlide Spinal Growth Guidance System OrthoPediatrics Corp. | PGM |
| Mar 7, 2025 | K243798 | Orthex External Fixation System OrthoPediatrics Corp. | KTT |
| Jan 20, 2024 | K233105 | RESPONSE Rib and Pelvic System OrthoPediatrics Corp. | MDI |
| Aug 21, 2023 | K231266 | Pediatric Nailing Platform Tibia OrthoPediatrics Corp. | HSB |
| Mar 23, 2023 | K222105 | RESPONSE 5.5/6.0 Cannulated Screw System OrthoPediatrics Corp. | NKB |
| Feb 10, 2023 | K223786 | Orthex External Fixation System OrthoPediatrics Corp. | KTT |
| Jul 20, 2022 | K220679 | Pediatric Nailing Platform Femur OrthoPediatrics Corp. | HSB |
| Apr 8, 2022 | K220809 | Drive Rail System OrthoPediatrics Corp. | KTT |
| Feb 4, 2021 | K203573 | RESPONSE Navigation Instruments OrthoPediatrics Corp. | OLO |
| Jan 29, 2021 | K201838 | PediFlex Flexible Nail System OrthoPediatrics Corp. | HTY |
| Mar 24, 2020 | K193100 | RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System OrthoPediatrics Corp. | NKB |
| Mar 16, 2020 | K200097 | Response BandLoc Spinal Fixation OrthoPediatrics Corp. | OWI |
| Oct 9, 2019 | K190321 | Pediatric Nailing PlatformFemur OrthoPediatrics Corp. | HSB |
| Aug 6, 2019 | K190992 | OrthoPediatrics PediFoot Deformity Corrections System OrthoPediatrics Corp. | HRS |
| Jul 5, 2019 | K190324 | OrthoPediatrics Cannulated Screw System OrthoPediatrics Corp. | HWC |
| Sep 18, 2018 | K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System OrthoPediatrics Corp. | NKB |
| May 10, 2018 | K172583 | OrthoPediatrics PediNail Intramedullary Platform Orthopediatrics, Inc. | HSB |
| Dec 6, 2017 | K172425 | OrthoPediatrics Wrist Fusion Plate Orthopediatrics, Inc. | HRS |
| Aug 24, 2017 | K171173 | OrthoPediatrics Titanium PediPlates® System OrthoPediatrics Corp. | HRS |
| Sep 27, 2016 | K162307 | OrthoPediatrics Locking Proximal Femur System Cortical Screws OrthoPediatrics Corp. | HRS |
| Aug 11, 2016 | K161267 | Response BandLoc Spinal Fixation OrthoPediatrics Corp. | OWI |
| Mar 23, 2016 | K160466 | Response 5.5 Spine System OrthoPediatrics Corp. | NKB |
| May 22, 2015 | K150600 | Response 5.5/6.0 Spine System OrthoPediatrics Corp. | NKB |
| Jul 29, 2014 | K140431 | PEDILOC FRAGMENT SYSTEM OrthoPediatrics Corp. | HRS |
| Jun 20, 2013 | K130217 | ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM OrthoPediatrics Corp. | MBI |
| May 8, 2013 | K130655 | RESPONSE SPINE SYSTEM OrthoPediatrics Corp. | OSH |
| Jun 19, 2012 | K121250 | OP SPINE SYSTEM OrthoPediatrics Corp. | OSH |
| Apr 16, 2012 | K120291 | OP SPINE SYSTEM OrthoPediatrics Corp. | OSH |
| Aug 5, 2011 | K110959 | ORTHOPEDIATRICS BLADE PLATE SYSTEM OrthoPediatrics Corp. | HRS |
| Jun 17, 2011 | K111086 | ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM OrthoPediatrics Corp. | HRS |
| May 17, 2010 | K100240 | ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM OrthoPediatrics Corp. | HRS |
| Apr 24, 2009 | K090666 | PEDIPLATES OrthoPediatrics Corp. | HRS |
| Mar 11, 2009 | K083726 | PEDINAIL INTRAMEDULLARY NAILING SYSTEM OrthoPediatrics Corp. | HSB |
| Jan 30, 2009 | K083286 | ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM OrthoPediatrics Corp. | HRS |
| Nov 25, 2008 | K082949 | ORTHOPEDIATRICS BONE SCREWS OrthoPediatrics Corp. | HWC |
| Oct 17, 2008 | K082375 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM OrthoPediatrics Corp. | HTY |
| Jul 22, 2008 | K081407 | ORTHOPEDIATRICS PEDIPLATES SYSTEM OrthoPediatrics Corp. | HRS |
| Jun 3, 2008 | K081097 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM Orthopediatrics, LLC | HTY |
| Feb 19, 2008 | K073344 | ORTHOPEDIATRICS PLATING SYSTEM Orthopediatrics, LLC | HRS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2022 | OrthoPediatrics Corp Orthex Large Bone Shoulder Bolt, model no. AS-17 Open, Classified |
OSN | K151881 |
| Jun 29, 2022 | OrthoPediatrics Corp Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm
Model: K400-18BN Open, Classified |
KTT | K151881 |
| Jul 6, 2020 | OrthoPediatrics Corp Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and
stabilization of the posterior, non-cervical spine in skeletally mature pati Open, Classified |
NKB | K150600 |
| Jun 5, 2020 | OrthoPediatrics Corp OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction Terminated |
MBI | None listed |
| Jun 5, 2020 | OrthoPediatrics Corp OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction Terminated |
MBI | K130217 |
| Aug 19, 2019 | OrthoPediatrics Corp Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation r Terminated |
HSB | K172583 |
| Aug 19, 2019 | OrthoPediatrics Corp Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (pr Terminated |
HSB | K172583 |
| Aug 19, 2019 | OrthoPediatrics Corp OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system
(bolt is used to attach the targeting arm to the int Terminated |
HSB | K172583 |
| Aug 3, 2017 | OrthoPediatrics Corp Response 5.5/6.0 Spine System 7.0mm x 40mm
Pedicle Screw
Product Usage:
Posterior non-cervical pedicle screw fixation Terminated |
OSH | K150600 |
| Apr 24, 2017 | OrthoPediatrics Corp Response BandLoc 5.5/6.0 Tensioner Instrument
The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine m Terminated |
OWI | K161267 |
| Dec 22, 2016 | OrthoPediatrics Corp OrthoPediatrics PediNail Intramedullary Nailing System
4.5mm X 48mm Cortical Screw Terminated |
HSB | K083726 |
| Sep 19, 2016 | OrthoPediatrics Corp 3.5mm Bowed Locking Compression Femur Plates, 18 hole
Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and in Terminated |
HWC | K083286 |
| Sep 19, 2016 | OrthoPediatrics Corp 3.5mm Bowed Locking Compression Femur Plates, 14 hole
Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and in Terminated |
HWC | K083286 |
| Nov 10, 2015 | OrthoPediatrics Corp UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw
The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature Terminated |
NKB | K150600 |
| Sep 18, 2015 | OrthoPediatrics Corp 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System
Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics. Terminated |
HRS | K111086 |
| Aug 29, 2014 | OrthoPediatrics Corp ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm
Product Usage:
The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL recon Terminated |
MBI | K130217 |
| Feb 6, 2014 | OrthoPediatrics Corp 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm
Part No. 00-0903-2620
OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatr Terminated |
HWC | None listed |
| Dec 26, 2013 | OrthoPediatrics Corp OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm Terminated |
MBI | K130217 |
| Nov 14, 2013 | OrthoPediatrics Corp 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM
The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages o Terminated |
HRS | None listed |
| Aug 9, 2013 | OrthoPediatrics Corp 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw. Terminated |
HWC | K083286 |
| Jun 12, 2013 | OrthoPediatrics Corp 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole
Product Usage:
The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies i Terminated |
HWC | K110959 |
| Jun 12, 2013 | OrthoPediatrics Corp 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole
Product Usage:
The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies i Terminated |
HWC | K110959 |
| Jun 12, 2013 | OrthoPediatrics Corp 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole
Product Usage:
The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies i Terminated |
HWC | K110959 |
| Nov 22, 2012 | OrthoPediatrics Corp 4.5mm PLEO Osteotomy Guide.
OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Terminated |
HRS | K083286 |
| Nov 5, 2012 | OrthoPediatrics Corp Trochar Scalpel Instrument (Surgical Punch)
OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended Terminated |
HSB | K024173 |
| Jul 20, 2012 | OrthoPediatrics Corp OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right.
Used for pediatric patients as indicated for pelvic, small and long bone fractures. Terminated |
HRS | K083286 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-087.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-086.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-085.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-084.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-083.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-082.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-081.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-076.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-075.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-074.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-073.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-072.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-071.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-037.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-036.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-035.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-034.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-033.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-032.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-031.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-026.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 28 cm, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-025.
The system is used for pediatric and small stature adult patients to stabilize fractures o Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-024.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-023.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
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