# K802462: Synthes Spinal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 16, 1980 after 69 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
696 later devices descend from it; 2 cite it directly.
1 of 697 devices in its family (counting itself) has 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
- K042499: Orion Anterior Cervical Plating System (2004), 694 descendants of its own
- K042922: Venture Anterior Cervical Plating System (2004), 677 descendants of its own
- K061274: Venture Anterior Cervical Plate System (2006), 669 descendants of its own
- K073285: Peek Prevail Cervical Interbody Device (2008), 637 descendants of its own
- K094042: Peek Prevail Cervical Interbody Device (2010), 397 descendants of its own

Source page: https://510kreport.com/device/K802462
Methodology: https://510kreport.com/methodology