I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
FDA 510(k) clearance K260958 · decided 2026-06-16
Clearance details
- K-number
- K260958
- Device name
- I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
- Applicant
- I.T.S. GmbH
- Decision
- Substantially Equivalent
- Date received
- 2026-03-23
- Decision date
- 2026-06-16
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Laßnitzhöhe, AT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Xpert Ankle (K261511) | Newclip Technics | 2026-07-28 |
| Versalock Proximal Tibial Plating System (K261406) | GM Dos Reis Industria e Comercio Ltda. | 2026-07-21 |
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| Alians Elbow S (K261191) | Newclip Technics | 2026-07-08 |
| RibPlate System (K261054) | Stryker Leibinger GmbH & Co KG | 2026-07-01 |
| SALGINA 2.5mm Distal Radius System (K261351) | Bonebridge AG | 2026-06-26 |
| Exalta Proximal Tibia Plating System (K261207) | Tyber Medical, LLC | 2026-06-12 |
| APTUS Clavicle System 2.8 (K260761) | Medartis AG | 2026-06-05 |
| Pectus Blu System (K261002) | Biomet Microfixation | 2026-06-02 |
| Xpert PFP (K261038) | Newclip Technics | 2026-05-29 |
| Avanti Distal Elbow ORIF System (K261145) | Avanti Orthopaedics, LLC | 2026-05-09 |
| OrthoPediatrics® Locking Cannulated Blade Plate System (K260323) | OrthoPediatrics Corp. | 2026-04-30 |
Recalls involving this device
No recalls on record reference this clearance.