# K240526: POWEReam Xia/Serrato

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Apr 29, 2024 after 66 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K040583 (2004). 181 ancestors in all.
No later device cites it as a predicate yet.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233300: POWEReam 1/4 Drive, Stryker Instruments (2023) Summary page 4.

## Indications for use
The intended use is to facilitate the placement of the pedicle screws using the power technique (cordless). When the attachment is attached, the Stryker Power Tools provide power to rotate the screwdrivers for the insertion of pedicle screws. Pedicle screws from select Stryker Spine implant systems may be implemented in the non-cervical spine using powered instrumentation.

Source page: https://510kreport.com/device/K240526
Methodology: https://510kreport.com/methodology