OrthoPediatrics Corp.
Medical device manufacturer in Warsaw, IN.
44510(k) clearances
0PMA approvals
51recalls
Device types
- HRS Plate, Fixation, Bone 15
- HSB Rod, Fixation, Intramedullary And Accessories 6
- NKB Thoracolumbosacral Pedicle Screw System 5
- HTY Pin, Fixation, Smooth 4
- OSH Pedicle Screw Spinal System, Adolescent… 3
- KTT Appliance, Fixation, Nail/Blade/Plate… 3
- HWC Screw, Fixation, Bone 2
- OWI Bone Fixation Cerclage, Sublaminar 2
- MBI Fastener, Fixation, Nondegradable, Soft… 1
- OLO Orthopedic Stereotaxic Instrument 1
- MDI Prosthesis, Rib Replacement 1
- PGM Growing Rod System 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate SystemHRS · Traditional | 04/30/2026SE |
| K252600 | Pediatric Plating Platform I Small-MiniHRS · Traditional | 10/09/2025SE |
| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | 06/24/2025SE |
| K243963 | Pediatric Plating Platform HipHRS · Traditional | 04/29/2025SE |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurHSB · Special | 04/01/2025SE |
| K241816 | VerteGlide Spinal Growth Guidance SystemPGM · Traditional | 03/14/2025SE |
| K243798 | Orthex External Fixation SystemKTT · Traditional | 03/07/2025SE |
| K233105 | RESPONSE Rib and Pelvic SystemMDI · Traditional | 01/20/2024SE |
| K231266 | Pediatric Nailing Platform TibiaHSB · Traditional | 08/21/2023SE |
| K222105 | RESPONSE 5.5/6.0 Cannulated Screw SystemNKB · Special | 03/23/2023SE |
| K223786 | Orthex External Fixation SystemKTT · Traditional | 02/10/2023SE |
| K220679 | Pediatric Nailing Platform FemurHSB · Traditional | 07/20/2022SE |
| K220809 | Drive Rail SystemKTT · Special | 04/08/2022SE |
| K203573 | RESPONSE Navigation InstrumentsOLO · Traditional | 02/04/2021SE |
| K201838 | PediFlex Flexible Nail SystemHTY · Traditional | 01/29/2021SE |
| K193100 | RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine SystemNKB · Traditional | 03/24/2020SE |
| K200097 | Response BandLoc Spinal FixationOWI · Traditional | 03/16/2020SE |
| K190321 | Pediatric Nailing PlatformFemurHSB · Special | 10/09/2019SE |
| K190992 | OrthoPediatrics PediFoot Deformity Corrections SystemHRS · Traditional | 08/06/2019SE |
| K190324 | OrthoPediatrics Cannulated Screw SystemHWC · Traditional | 07/05/2019SE |
| K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemNKB · Traditional | 09/18/2018SE |
| K172583 | OrthoPediatrics PediNail Intramedullary PlatformHSB · Traditional | 05/10/2018SE |
| K172425 | OrthoPediatrics Wrist Fusion PlateHRS · Traditional | 12/06/2017SE |
| K171173 | OrthoPediatrics Titanium PediPlates® SystemHRS · Traditional | 08/24/2017SE |
| K162307 | OrthoPediatrics Locking Proximal Femur System Cortical ScrewsHRS · Special | 09/27/2016SE |
| K161267 | Response BandLoc Spinal FixationOWI · Traditional | 08/11/2016SE |
| K160466 | Response 5.5 Spine SystemNKB · Traditional | 03/23/2016SE |
| K150600 | Response 5.5/6.0 Spine SystemNKB · Traditional | 05/22/2015SE |
| K140431 | Pediloc Fragment SystemHRS · Traditional | 07/29/2014SE |
| K130217 | Orthopediatrics Acl Reconstructive SystemMBI · Traditional | 06/20/2013SE |
| K130655 | Response Spine SystemOSH · Traditional | 05/08/2013SE |
| K121250 | Op Spine SystemOSH · Special | 06/19/2012SESU |
| K120291 | Op Spine SystemOSH · Traditional | 04/16/2012SESU |
| K110959 | Orthopediatrics Blade Plate SystemHRS · Traditional | 08/05/2011SE |
| K111086 | Orthopediatrics Fracture and Osteotomy Bone Plate SystemHRS · Traditional | 06/17/2011SE |
| K100240 | Orthopediatrics Pediloc Tibia Plate SystemHRS · Traditional | 05/17/2010SE |
| K090666 | PediplatesHRS · Traditional | 04/24/2009SE |
| K083726 | Pedinail Intramedullary Nailing SystemHSB · Traditional | 03/11/2009SE |
| K083286 | Orthopediatrics Pediloc Locking Plate SystemHRS · Traditional | 01/30/2009SE |
| K082949 | Orthopediatrics Bone ScrewsHWC · Traditional | 11/25/2008SE |
| K082375 | Orthopediatrics Pediflex Flexible Nail SystemHTY · Traditional | 10/17/2008SE |
| K081407 | Orthopediatrics Pediplates SystemHRS · Traditional | 07/22/2008SE |
| K081097 | Orthopediatrics Pediflex Flexible Nail SystemHTY · Traditional | 06/03/2008SE |
| K073344 | Orthopediatrics Plating SystemHRS · Traditional | 02/19/2008SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0277-2023 Class II | Orthex Large Bone Shoulder Bolt, model no. AS-17Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may… | 09/12/2022Open, Classified |
| Z-1678-2022 Class II | Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BNManufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The… | 06/29/2022Open, Classified |
| Z-2742-2020 Class II | Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System…Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised… | 07/06/2020Open, Classified |
| Z-2539-2020 Class II | OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number…ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size.… | 06/05/2020Terminated |
| Z-2538-2020 Class II | OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number…ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size.… | 06/05/2020Terminated |
| Z-0219-2020 Class II | Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric…Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical… | 08/19/2019Terminated |
| Z-0218-2020 Class II | Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing…Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical… | 08/19/2019Terminated |
| Z-0125-2020 Class II | OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform…Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in… | 08/19/2019Terminated |
| Z-0597-2018 Class II | Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior…The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm… | 08/03/2017Terminated |
| Z-2321-2017 Class II | Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is…Over-tensioning of the band resulting in damage to the band causing it to rupture | 04/24/2017Terminated |
| Z-0879-2017 Class III | OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical ScrewLabeled as a 48mm Cortical Screw but measuring at 50mm | 11/18/2016Terminated |
| Z-2844-2016 Class II | 3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking…OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur… | 07/27/2016Terminated |
| Z-2843-2016 Class II | 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking…OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur… | 07/27/2016Terminated |
| Z-0622-2016 Class II | UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine…Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly… | 11/10/2015Terminated |
| Z-2796-2015 Class II | 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number…The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different… | 07/28/2015Terminated |
| Z-2560-2014 Class II | ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm…Weld fractures on the Sleeve Installation Tool for ACL reconstruction system. | 07/25/2014Terminated |
| Z-0934-2014 Class II | 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No.…OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot #… | 01/08/2014Terminated |
| Z-0579-2014 Class II | OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL…Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6… | 11/07/2013Terminated |
| Z-0276-2014 Class II | 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur…The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a… | 09/26/2013Terminated |
| Z-1941-2013 Class II | 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to…OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only… | 07/24/2013Terminated |
| Z-1536-2013 Class II | 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The…Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five… | 04/19/2013Terminated |
| Z-1535-2013 Class II | 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The…Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five… | 04/19/2013Terminated |
| Z-1534-2013 Class II | 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The…Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five… | 04/19/2013Terminated |
| Z-0432-2013 Class II | 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension…Complaint received from sales representative that the drill guide tubes would not screw into replenishment… | 10/18/2012Terminated |
| Z-0207-2013 Class II | Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails)…A complaint received from sales representative that a replenishment instrument was too short. Upon… | 09/13/2012Terminated |
| Z-2057-2012 Class II | OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8…The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. | 06/14/2012Terminated |
| Z-0364-2010 | Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0363-2010 | Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0362-2010 | Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0361-2010 | Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0360-2010 | Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0359-2010 | Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0358-2010 | Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0357-2010 | Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0356-2010 | Orthopediatrics IM Femoral Nail - 7mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0355-2010 | Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0354-2010 | Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0353-2010 | Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0352-2010 | Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0351-2010 | Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0350-2010 | Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0349-2010 | Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0348-2010 | Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0347-2010 | Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0346-2010 | Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0345-2010 | Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0344-2010 | Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0343-2010 | Orthopediatrics IM Femoral Nail - 7mm x 28 cm, non-sterile, Orthopediatrics, Warsaw, IN…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0342-2010 | Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0341-2010 | Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0339-2010 | Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |