# K211086: The Progen™ Trochanteric Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corporation
- Decided: Dec 21, 2021 after 253 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K013468 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 4.
- K040212: Trigen Intertan, Smith & Nephew, Inc. (2004) Summary page 4.

## Indications for use
The Progen™ short trochanteric nail is indicated for fixation of various types of stable and unstable neck, intertrochanteric, and peritrochanteric fractures. The Progen™ long trochanteric nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, malunion, and revisions.

Source page: https://510kreport.com/device/K211086
Methodology: https://510kreport.com/methodology