Warsaw, IN, US · 6 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | 3 | 2023-06-16 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | 2 | 2023-03-29 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | 1 | 2020-12-23 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-04-05 | Class II | Ongoing | Z-1808-2024 | WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device. | — | The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated. |
| 2023-01-04 | Class II | Ongoing | Z-1102-2023 | WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Numb… | — | Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This m… |
| 2021-04-30 | Class II | Terminated | Z-1794-2021 | WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK… | — | Nonconformities were discovered to the engineering specifications for implant plates and screws. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-06-16 | K231461 | Smart Correction System (HA Half Pins) | KTT | Class II | Orthopedic |
| 2023-03-29 | K230527 | WishBone Medical Plate and Screw System | HRS | Class II | Orthopedic |
| 2022-06-06 | K221366 | Smart Correction System Rings and Compatible HA-Coated Half Pins | KTT | Class II | Orthopedic |
| 2022-01-27 | K213489 | Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate | HRS | Class II | Orthopedic |
| 2020-12-23 | K203467 | WishBone Medical Plate and Screw System | HWC | Class II | Orthopedic |
| 2020-09-18 | K193368 | Smart Correction System | KTT | Class II | Orthopedic |