Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA— 510(k) K253991
Substantially EquivalentOrthofix Srl
FDA 510(k) clearance K253991 for Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA, Substantially Equivalent on 2026-05-08. Applicant: Orthofix Srl. Device class: 2.
Summary
Orthofix's record covers three items: Fitbone Trochanteric, the FITBONE Transport and Lengthening System, and FITBONE TAA. The product code is HSB, intramedullary fixation rods and accessories.
Class II, 21 CFR 888.3020. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
Orthofix filed from Bussolengo (Vr), Italy. Review took 147 calendar days (December 12, 2025 to May 8, 2026).
Clearance details
- Applicant
- Orthofix Srl
- Product code
- Product code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bussolengo (Vr), IT
Recent devices under product code HSB
view allMore clearances from Orthofix Srl
view allAdverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.