# K963332: Thermo-Plastic Shaver Blades

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Oct 11, 1996 after 49 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 K940515 (1994). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940515: Poly Blades, Linvatec Corp. (1994) Summary page 1.

## Most influential descendants
- K060172: Rema Shaver Blades (2006), 0 descendants of its own
- K012635: Reprocessed Stryker Arthroscopic Shavers (2001), 0 descendants of its own
- K012605: Reprocessed Athroscopics Burs (2001), 0 descendants of its own

## Indications for use
The disposable Thermo-Plastic Shaver Blades are for orthopedic use and will be provided sterile for single use applications.

Source page: https://510kreport.com/device/K963332
Methodology: https://510kreport.com/methodology