# K240071: Peleton Universal Single Use Power System and Attachments

- Pathway: 510(k) (Traditional)
- Applicant: Peleton Surgical
- Decided: Apr 4, 2024 after 85 days
- Product code: SAM (Battery-Powered Instruments Charged Through Sterile Barriers)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972367 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112599: Insurgical Single Use Power Equipment, Insurgical, LLC (2012) Summary page 5.
- K972367: Stryker System 4000 Heavy Duty Battery Powered Equipment, Stryker Instruments (1997) Summary page 5.

## Indications for use
The Peleton Surgical Single Use Power Tool System is a battery driven tool system for use in Trauma, Orthopaedic and Cardio related Surgical Procedures involving drilling, reaming, pin & wire placement and cutting of bone and hard tissue.

Source page: https://510kreport.com/device/K240071
Methodology: https://510kreport.com/methodology