# K233300: POWEReam 1/4 Drive

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Dec 26, 2023 after 88 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: 20 generations back to K040583 (2004). 180 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200666: Stryker Xia 3 Power Adaptor, Stryker Spine (2020) Summary page 4.

## Most influential descendants
- K240526: POWEReam Xia/Serrato (2024), 0 descendants of its own

## Indications for use
The intended use is for drilling, reaming, and decorticating of bone and other bone-related tissue during general surgical orthopedic procedures in a variety of surgical procedures. It is also usable in the placement of screws, wires, pins, and other fixation devices. This attachment is designed for general surgical use where hard tissue and/or bone must be cut, reamed, drilled, and/or fixated with screws, including but not limited to, the hand, wrist, elbow, sternum, shoulder, foot, ankle, knee, and hip. The intended use is also 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, in non-cervical spine surgical procedures.

Source page: https://510kreport.com/device/K233300
Methodology: https://510kreport.com/methodology