# K940515: Poly Blades

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: May 26, 1994 after 111 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K963332: Thermo-Plastic Shaver Blades (1996), 3 descendants of its own
- K060172: Rema Shaver Blades (2006), 0 descendants of its own
- K012630: Reprocessed Linvatec Arthroscopic Burs (2001), 0 descendants of its own
- K012613: Reprocssed Linvatec Shavers (2001), 0 descendants of its own
- K012635: Reprocessed Stryker Arthroscopic Shavers (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K940515
Methodology: https://510kreport.com/methodology