Pangea Femur Reconstruction System— 510(k) K261481
Substantially EquivalentStryker GmbH
FDA 510(k) clearance K261481 for Pangea Femur Reconstruction System, Substantially Equivalent on 2026-06-29. Applicant: Stryker GmbH. Device class: 2.
Summary
Stryker GmbH's Pangea Femur Reconstruction System is filed under HSB, intramedullary fixation rods and accessories. The record doesn't list the system's components.
Class II, 21 CFR 888.3020. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
Stryker filed from Selzach, Switzerland. The decision came 55 calendar days after receipt (May 5 to June 29, 2026).
Clearance details
- Applicant
- Stryker GmbH
- 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
- Selzach, CH
Recent devices under product code HSB
view allMore clearances from Stryker GmbH
view all- K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
- K253202 — Hoffmann LRF System
- K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
- K250163 — T2 Alpha Femur Retrograde Nailing System
- K242445 — Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System
Adverse 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.