OrthoPediatrics Corp.
OrthoPediatrics Corp. holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2026, with 26 FDA device recalls on record.
Top product codes for OrthoPediatrics Corp.
FDA recalls by OrthoPediatrics Corp.
10 most recent of 26- Z-0277-2023 — Orthex Large Bone Shoulder Bolt, model no. AS-17
- Z-1678-2022 — Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
- Z-2742-2020 — 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 to fusion for the following indications: degenerative disc disease Model Number: 00-1300-6053
- Z-2538-2020 — 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 Anterior Cruciate Ligament (ACL) Reconstruction.
- Z-2539-2020 — 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 procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
- Z-0219-2020 — 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 rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.
- Z-0218-2020 — 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 attachment bolts are one component of the surgical instruments within the system.
- Z-0125-2020 — 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 rod) Part number: 01-1503-0032
- Z-0597-2018 — Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
- Z-2321-2017 — 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 screw tightening.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by OrthoPediatrics Corp.
- K260323 — OrthoPediatrics® Locking Cannulated Blade Plate System
- K252600 — Pediatric Plating Platform I Small-Mini
- K251362 — PediFlex Flexible Nail System
- K243963 — Pediatric Plating Platform Hip
- K250623 — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur
- K241816 — VerteGlide Spinal Growth Guidance System
- K243798 — Orthex External Fixation System
- K233105 — RESPONSE Rib and Pelvic System
- K231266 — Pediatric Nailing Platform Tibia
- K222105 — RESPONSE 5.5/6.0 Cannulated Screw System
- K223786 — Orthex External Fixation System
- K220679 — Pediatric Nailing Platform Femur
- K220809 — Drive Rail System
- K203573 — RESPONSE Navigation Instruments
- K201838 — PediFlex Flexible Nail System
- K193100 — RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System
- K200097 — Response BandLoc Spinal Fixation
- K190321 — Pediatric Nailing PlatformFemur
- K190992 — OrthoPediatrics PediFoot Deformity Corrections System
- K190324 — OrthoPediatrics Cannulated Screw System
- K181390 — Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
- K171173 — OrthoPediatrics Titanium PediPlates® System
- K162307 — OrthoPediatrics Locking Proximal Femur System Cortical Screws
- K161267 — Response BandLoc Spinal Fixation
- K160466 — Response 5.5 Spine System
- K150600 — Response 5.5/6.0 Spine System
- K140431 — PEDILOC FRAGMENT SYSTEM
- K130217 — ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
- K130655 — RESPONSE SPINE SYSTEM
- K121250 — OP SPINE SYSTEM
- K120291 — OP SPINE SYSTEM
- K110959 — ORTHOPEDIATRICS BLADE PLATE SYSTEM
- K111086 — ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
- K100240 — ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM
- K090666 — PEDIPLATES
- K083726 — PEDINAIL INTRAMEDULLARY NAILING SYSTEM
- K083286 — ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM
- K082949 — ORTHOPEDIATRICS BONE SCREWS
- K082375 — ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
- K081407 — ORTHOPEDIATRICS PEDIPLATES SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.