# K963420: Cancellous Screw Washer

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Biosystems, Ltd.
- Decided: Nov 15, 1996 after 77 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
339 later devices descend from it; 2 cite it directly.
1 of 340 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Screw Washer: named in the summary without a submission number

## Most influential descendants
- K993762: I.CO.S Screw (2000), 338 descendants of its own
- K024233: Kompressor Screw System (2003), 299 descendants of its own
- K040356: Kompressor Screw System (2004), 255 descendants of its own
- K060071: Nexa Compression Screw (2006), 251 descendants of its own
- K063298: Osteomed Headless Cannulated Screw System (2007), 246 descendants of its own

## Indications for use
These implants are intended for fracture fixation of the metatarsals, metacarpals, and tarsal bones.

Source page: https://510kreport.com/device/K963420
Methodology: https://510kreport.com/methodology