# K940631: Cross Medical - Synergy (TM) Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Cross Medical Products, Inc.
- Decided: Jul 13, 1995 after 514 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
559 later devices descend from it; 16 cite it directly.
0 of 560 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
- K973836: Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System (1998), 529 descendants of its own
- K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems (1998), 311 descendants of its own
- K982914: Aesculap Spine System Evolution: Additional Components (1998), 251 descendants of its own
- K980484: Aesculap Spine System Evolution (1998), 251 descendants of its own
- K990118: Isobar Spinal System (1999), 250 descendants of its own

Source page: https://510kreport.com/device/K940631
Methodology: https://510kreport.com/methodology