# K954682: Washer, Bolt, Nut, Orthopedic

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Feb 9, 1996 after 121 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K081813: Universal Compression Fracture Repair System (2009), 4 descendants of its own
- K210754: Cannulated Fasteners and Nuts (2021), 3 descendants of its own
- K211290: Cannulated Fasteners and Nuts (2021), 2 descendants of its own
- K242691: OsteoCentric Technologies Cannulated Fasteners and Nuts (2024), 0 descendants of its own
- K230226: Integrity-SI® Fusion System (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K954682
Methodology: https://510kreport.com/methodology