# K934007: Sofamor Orfil Spine Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Co.
- Decided: Jun 2, 1994 after 288 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.
69 later devices descend from it; 1 cites it directly.
0 of 70 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
- K020426: MSD Wire System (2002), 68 descendants of its own
- K072605: Malibu Spinal System (2007), 67 descendants of its own
- K122571: Malibu Spinal System with the Daytona Deformity System (2012), 62 descendants of its own
- K160902: Mariner Pedicle Screw System (2016), 60 descendants of its own
- K173882: SeaSpine Mariner Pedicle Screw System (2018), 56 descendants of its own

Source page: https://510kreport.com/device/K934007
Methodology: https://510kreport.com/methodology