# K202749: ADAPT for Gamma3

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Dec 18, 2020 after 88 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: 12 generations back to K911783 (1994). 51 ancestors in all.
No later device cites it as a predicate yet.
1 of 52 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181848: ADAPT for Gamma3, Gamma3, Stryker GmbH (2018) Summary page 4.

## 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.

Source page: https://510kreport.com/device/K202749
Methodology: https://510kreport.com/methodology