T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System— 510(k) K253640
Substantially EquivalentStryker GmbH
FDA 510(k) clearance K253640 for T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System, Substantially Equivalent on 2026-02-03. Applicant: Stryker GmbH. Device class: 2.
Summary
Stryker GmbH lists two systems, the T2 Alpha Femur Retrograde Nailing System and the Pangea Femur Reconstruction System, under product code HSB (Rod, Fixation, Intramedullary And Accessories). The record doesn't describe either one beyond its name and that code name.
Class II, 21 CFR 888.3020. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
The record lists the applicant location as Selzach, Solothurn, Ch, with country code CH. FDA found it substantially equivalent 76 calendar days after receipt (November 19, 2025 to February 3, 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, Solothurn, Ch, CH
Recent devices under product code HSB
view allMore clearances from Stryker GmbH
view all- 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
- K233919 — VariAx 2 Distal Radius 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.