Warsaw, IN, US · 17 510(k) clearances · 5 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | 3 | 2026-04-30 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | 3 | 2025-04-01 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | 3 | 2025-03-07 |
| HTY | — | — | — | 2 | 2025-06-24 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 2 | 2023-03-23 |
| PGM | Growing Rod System | Class II | Orthopedic | 1 | 2025-03-14 |
| MDI | — | — | — | 1 | 2024-01-20 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 1 | 2021-02-04 |
| OWI | Bone Fixation Cerclage, Sublaminar | Class II | Orthopedic | 1 | 2020-03-16 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-09-12 | Class II | Ongoing | Z-0277-2023 | 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 disruptio… |
| 2022-06-29 | Class II | Ongoing | Z-1678-2022 | 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. Retrieva… |
| 2020-07-06 | Class II | Ongoing | Z-2742-2020 | Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization … | — | Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device |
| 2020-06-05 | Class II | Terminated | Z-2539-2020 | OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is … | — | 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 10-10… |
| 2020-06-05 | Class II | Terminated | Z-2538-2020 | OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is … | — | 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 10-10… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-30 | K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | HRS | Class II | Orthopedic |
| 2025-10-09 | K252600 | Pediatric Plating Platform I Small-Mini | HRS | Class II | Orthopedic |
| 2025-06-24 | K251362 | PediFlex Flexible Nail System | HTY | — | — |
| 2025-04-29 | K243963 | Pediatric Plating Platform Hip | HRS | Class II | Orthopedic |
| 2025-04-01 | K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | HSB | Class II | Orthopedic |
| 2025-03-14 | K241816 | VerteGlide Spinal Growth Guidance System | PGM | Class II | Orthopedic |
| 2025-03-07 | K243798 | Orthex External Fixation System | KTT | Class II | Orthopedic |
| 2024-01-20 | K233105 | RESPONSE Rib and Pelvic System | MDI | — | — |
| 2023-08-21 | K231266 | Pediatric Nailing Platform Tibia | HSB | Class II | Orthopedic |
| 2023-03-23 | K222105 | RESPONSE 5.5/6.0 Cannulated Screw System | NKB | Class II | Orthopedic |
| 2023-02-10 | K223786 | Orthex External Fixation System | KTT | Class II | Orthopedic |
| 2022-07-20 | K220679 | Pediatric Nailing Platform Femur | HSB | Class II | Orthopedic |
| 2022-04-08 | K220809 | Drive Rail System | KTT | Class II | Orthopedic |
| 2021-02-04 | K203573 | RESPONSE Navigation Instruments | OLO | Class II | Neurology |
| 2021-01-29 | K201838 | PediFlex Flexible Nail System | HTY | — | — |
| 2020-03-24 | K193100 | RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System | NKB | Class II | Orthopedic |
| 2020-03-16 | K200097 | Response BandLoc Spinal Fixation | OWI | Class II | Orthopedic |