Data / Medical devices / United States / Orthopediatrics, Corp
Orthopediatrics, Corp: FDA-registered device maker in Warsaw, IN, United States, 48 510(k) clearances
Orthopediatrics, Corp is registered with the FDA (registration 3006460162) in Warsaw, IN, United States. It lists 64 device types. The FDA files 48 510(k) clearances under its listings, the newest dated September 24, 2026. 22 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006460162
- Address
- 2850 Frontier Dr, Warsaw, IN, United States, 46582
- Owner or operator
- ORTHOPEDIATRICS, CORP (9102640)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- May 15, 2008
- Registered through
- 2026
- Brand names listed
- 3, 3.5, 7 Bone Screws, 4 Bone Screws, 6.5 and 7.3mm Large Fragment Cannulated Screw System, Aspire Ortho Spine System, Awl, BENDER, Bone Screw System, Cortical, Cancellous and Cannulated Bone Screws and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bender | HXW | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bit, Surgical | GFG | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bone Fixation Cerclage, Sublaminar | OWI | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp | HXD | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Fixation, Proximal Femoral, Implant | JDO | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Driver, Surgical, Pin | GFC | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| File | HTP | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps | HTD | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Growing Rod System | PGM | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hook, Bone | KIK | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mallet | HXL | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Passer | HWQ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | OBT | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prosthesis, Rib Replacement | MDI | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Protractor | HTH | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp | HTR | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Software For Diagnosis/Treatment | OSN | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stylet, Surgical, General & Plastic Surgery | GAH | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Table, Surgical With Orthopedic Accessories, Manual | JEB | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tamp | HXG | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 24, 2026 | K261345 | Pediatric Nailing Platform Femur | HSB | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| April 30, 2026 | K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | HRS | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| October 9, 2025 | K252600 | Pediatric Plating Platform I Small-Mini | HRS | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| June 24, 2025 | K251362 | PediFlex Flexible Nail System | HTY | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| April 29, 2025 | K243963 | Pediatric Plating Platform Hip | HRS | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| April 1, 2025 | K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | HSB | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| March 14, 2025 | K241816 | VerteGlide Spinal Growth Guidance System | PGM | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| March 7, 2025 | K243798 | Orthex External Fixation System | KTT | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| January 20, 2024 | K233105 | RESPONSE Rib and Pelvic System | MDI | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| August 21, 2023 | K231266 | Pediatric Nailing Platform Tibia | HSB | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| March 23, 2023 | K222105 | RESPONSE 5.5/6.0 Cannulated Screw System | NKB | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| February 10, 2023 | K223786 | Orthex External Fixation System | KTT | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| July 20, 2022 | K220679 | Pediatric Nailing Platform Femur | HSB | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| April 8, 2022 | K220809 | Drive Rail System | KTT | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| February 4, 2021 | K203573 | RESPONSE Navigation Instruments | OLO | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| January 29, 2021 | K201838 | PediFlex Flexible Nail System | HTY | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| March 24, 2020 | K193100 | RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System | NKB | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| March 16, 2020 | K200097 | Response BandLoc Spinal Fixation | OWI | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| October 9, 2019 | K190321 | Pediatric Nailing PlatformFemur | HSB | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| August 6, 2019 | K190992 | OrthoPediatrics PediFoot Deformity Corrections System | HRS | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| July 5, 2019 | K190324 | OrthoPediatrics Cannulated Screw System | HWC | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| September 18, 2018 | K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System | NKB | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| May 10, 2018 | K172583 | OrthoPediatrics PediNail Intramedullary Platform | HSB | Substantially Equivalent | Orthopediatrics, Inc. | accessdata.fda.gov |
| December 6, 2017 | K172425 | OrthoPediatrics Wrist Fusion Plate | HRS | Substantially Equivalent | Orthopediatrics, Inc. | accessdata.fda.gov |
| August 24, 2017 | K171173 | OrthoPediatrics Titanium PediPlates® System | HRS | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| February 13, 2017 | K163487 | Ultima HA Coated Half Pins and Wire | JDW | Substantially Equivalent | Vilex IN Tennessee, Inc. | accessdata.fda.gov |
| September 27, 2016 | K162307 | OrthoPediatrics Locking Proximal Femur System Cortical Screws | HRS | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| August 11, 2016 | K161267 | Response BandLoc Spinal Fixation | OWI | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| March 24, 2016 | K151881 | X-Fix Line Additions | KTT | Substantially Equivalent | Vilex IN Tennessee, Inc. | accessdata.fda.gov |
| March 23, 2016 | K160466 | Response 5.5 Spine System | NKB | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| May 22, 2015 | K150600 | Response 5.5/6.0 Spine System | NKB | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| July 29, 2014 | K140431 | PEDILOC FRAGMENT SYSTEM | HRS | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| July 23, 2014 | K132820 | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES | JDW | Substantially Equivalent | Vilex, Inc. | accessdata.fda.gov |
| May 29, 2014 | K140822 | DRIVE RAIL SYSTEM | KTT | Substantially Equivalent | Devise Ortho, Inc. | accessdata.fda.gov |
| June 20, 2013 | K130217 | ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM | MBI | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| May 8, 2013 | K130655 | RESPONSE SPINE SYSTEM | OSH | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| August 5, 2011 | K110959 | ORTHOPEDIATRICS BLADE PLATE SYSTEM | HRS | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| June 17, 2011 | K111086 | ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM | HRS | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| May 17, 2010 | K100240 | ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM | HRS | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| April 24, 2009 | K090666 | PEDIPLATES | HRS | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| March 11, 2009 | K083726 | PEDINAIL INTRAMEDULLARY NAILING SYSTEM | HSB | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| January 30, 2009 | K083286 | ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM | HRS | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| November 25, 2008 | K082949 | ORTHOPEDIATRICS BONE SCREWS | HWC | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| October 17, 2008 | K082375 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM | HTY | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| July 22, 2008 | K081407 | ORTHOPEDIATRICS PEDIPLATES SYSTEM | HRS | Substantially Equivalent | OrthoPediatrics Corp. | accessdata.fda.gov |
| June 3, 2008 | K081097 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM | HTY | Substantially Equivalent | Orthopediatrics, LLC | accessdata.fda.gov |
| February 19, 2008 | K073344 | ORTHOPEDIATRICS PLATING SYSTEM | HRS | Substantially Equivalent | Orthopediatrics, LLC | accessdata.fda.gov |
| November 22, 2005 | K052196 | VILEX X-FIX | KTT | Substantially Equivalent | Vilex, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 12, 2022 | 91098 | Class II | Ongoing | Orthex Large Bone Shoulder Bolt, model no. AS-17 | Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration. | accessdata.fda.gov |
| June 29, 2022 | 90738 | Class II | Ongoing | Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN | Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time | accessdata.fda.gov |
| July 6, 2020 | 86027 | Class II | Ongoing | 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 patients as an adjunct t | Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device | accessdata.fda.gov |
| June 5, 2020 | 85837 | Class II | Terminated | 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 procedures such as A | ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package. | accessdata.fda.gov |
| August 19, 2019 | 83884 | Class II | Terminated | 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 (product code HSB). The | Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. | accessdata.fda.gov |
| August 19, 2019 | 83767 | Class II | Terminated | 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 intramedullary fixation r | Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures | accessdata.fda.gov |
| August 3, 2017 | 79067 | Class II | Terminated | Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation | The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws. | accessdata.fda.gov |
| April 24, 2017 | 77270 | Class II | Terminated | 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 manipulation and set scr | Over-tensioning of the band resulting in damage to the band causing it to rupture | accessdata.fda.gov |
| November 18, 2016 | 75758 | Class III | Terminated | OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw | Labeled as a 48mm Cortical Screw but measuring at 50mm | accessdata.fda.gov |
| July 27, 2016 | 74928 | Class II | Terminated | 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 instrumentation in one | OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled. | accessdata.fda.gov |
| November 10, 2015 | 72962 | Class II | Terminated | 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 patients as an adjunc | Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw. | accessdata.fda.gov |
| July 28, 2015 | 71933 | Class II | Terminated | 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. | The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly. | accessdata.fda.gov |
| July 25, 2014 | 69050 | Class II | Terminated | 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 reconstruction system that | Weld fractures on the Sleeve Installation Tool for ACL reconstruction system. | accessdata.fda.gov |
| January 8, 2014 | 67302 | Class II | Terminated | 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 pediatric and small stature | OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524. | accessdata.fda.gov |
| November 7, 2013 | 67003 | Class II | Terminated | 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, 8.5mm, 9mm, and 10m | Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size. | accessdata.fda.gov |
| September 26, 2013 | 66450 | Class II | Terminated | 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 of the osteotomy blade | The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics. | accessdata.fda.gov |
| July 24, 2013 | 65828 | Class II | Terminated | 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. | OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding o | accessdata.fda.gov |
| April 19, 2013 | 65091 | Class II | Terminated | 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 in all pediatric subgro | Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively. | accessdata.fda.gov |
| October 18, 2012 | 63554 | Class II | Terminated | 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 Plate ( PLEO ). The | Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended. | accessdata.fda.gov |
| September 13, 2012 | 63396 | Class II | Terminated | 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 to be inserted into t | A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended. | accessdata.fda.gov |
| June 14, 2012 | 62351 | Class II | Terminated | 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. | The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. | accessdata.fda.gov |
| July 21, 2009 | 52852 | Not yet classified | Terminated | Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-021. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral sha | The potential exists for the nails to fracture during insertion of the nail. | accessdata.fda.gov |
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- All makers of Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- All makers of Appliance, Fixation, Spinal Interlaminal
Updated September 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.