# K011437: Synergy 4.0 MM, 4.5 MM VLS Screws

- Pathway: 510(k) (Special)
- Applicant: Interpore Cross Intl.
- Decided: Jun 6, 2001 after 27 days
- Product code: MNI (Orthosis, Spinal Pedicle 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.
325 later devices descend from it; 12 cite it directly.
0 of 326 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
- K090203: 5.5 Helical Flange Spinal System, Polaris Components (2009), 154 descendants of its own
- K100220: Polaris Spinal System (2010), 153 descendants of its own
- K120291: OP Spine System (2012), 138 descendants of its own
- K121630: Range Spinal System (2012), 127 descendants of its own
- K103393: Polaris Spinal System (2011), 104 descendants of its own

Source page: https://510kreport.com/device/K011437
Methodology: https://510kreport.com/methodology