# K172092: Reprocessed Shavers/Burs

- Pathway: 510(k) (Traditional)
- Applicant: Renovo, Inc.
- Decided: Oct 4, 2017 after 85 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: 2 generations back to K953096 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973195: Total Performance System Shaver, Stryker Endoscopy (1997) Summary page 19.
- K981636: Integrated Drive/Pump System, Linvatec Corp. (1998) Summary page 19.
- K062849: Smith & Nephew Duonics Power II Shaver System, Smith & Nephew, Inc. (2007) Summary page 19.

## Indications for use
The Reprocessed Linvatec shavers and burs are intended for use with the Linvatec Integrated Drive/Pump System to perform resection of soft tissue and bone. The fields of application include Otolaryngology, Neurological Surgical, Orthopedic, and Spinal surgical procedures. The Reprocessed Smith & Nephew shavers and burs are intended for use with the Smith & Nephew DYONICS Power 11 Shaver System control unit, for resection of soft and osseous tissues including but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure. The Reprocessed Styker Shavers and Burs are intended for use with the Styker Total Performance System Shaver handpiece and the Stryker Total Performance System by surgeons in the following orthopedic joints: > Knee > Shoulder > Ankle > Elbow > Wrist > Hip > Temporamandibular The Reprocessed Styker Shavers and Burs will be used to resect tissue and bur bone. Examples of uses of the product would include resection of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints.

Source page: https://510kreport.com/device/K172092
Methodology: https://510kreport.com/methodology