# K181848: ADAPT for Gamma3, Gamma3

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Oct 12, 2018 after 93 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K911783 (1994). 50 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 52 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173946: ADAPT for Gamma3, Stryker GmbH (2018) Summary page 5.
- K123401: GAMMA3 and T2 Recon Targeting Devices, Stryker Trauma AG (2013) Summary page 5.
- K141551: Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees) Suction, Profess Curved 90 (Degrees), Stryker Corporate (2014) Summary page 5.

## Most influential descendants
- K202749: ADAPT for Gamma3 (2020), 0 descendants of its own

## Indications for use
The ADAPT for Gamma3 System, when used with the Stryker Navigation System, assists the surgeon to determine the needed size and position of orthopedic implants during femur fracture surgery using the Gamma3 System. When used in operation the system should be operated only by trained personnel such as surgeons and clinic staff. The Trochanteric Gamma3 Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3 Nail indication may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.

Source page: https://510kreport.com/device/K181848
Methodology: https://510kreport.com/methodology