# K020761: Power Tek II

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Apr 3, 2002 after 27 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920800 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920800: Integrated Endoscopy System 1000, Biomet, Inc. (1992) Summary page 1.

## Indications for use
The Power Tek Il shaver system is a powered instrument for orthopedic applications including abrasion arthroplasty, synovectomy or intra-articular cutting and shaving. The device is intended for use in the knee, shoulder, wrist, temporal-mandibular joint, ankle, and elbow.

Source page: https://510kreport.com/device/K020761
Methodology: https://510kreport.com/methodology