# K971692: Osteopower System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Corp.
- Decided: Jun 27, 1997 after 51 days
- Product code: KMW (Handpiece, Rotary Bone Cutting)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K994298: Frios Microsaw (2000), 0 descendants of its own

## Recalls of this device
- Oct 28, 2021 · Class II · Z-0335-2022: Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.

## Indications for use
Osteomed Corporation intends to market the OsteoPower System and Accessories for drilling or cutting bone or teeth, and for driving screws and/or pins and wires into bone, in conjunction with dental, craniofacial, craniotomies, orthognathic, spinal, mandibular, hand, foot, wrist, and extremity reconstruction surgical procedures.

Source page: https://510kreport.com/device/K971692
Methodology: https://510kreport.com/methodology