# K010515: Modification to Synergy Spinal System

- Pathway: 510(k) (Special)
- Applicant: Interpore Cross Intl.
- Decided: Mar 22, 2001 after 28 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.
18 later devices descend from it; 4 cite it directly.
0 of 19 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
- K072426: Atlas Spine Pedicle Screw System (2007), 5 descendants of its own
- K232341: CarboClear® Pedicle Screw System (2023), 4 descendants of its own
- K110842: Atlas Spine Pedicle Screw System (2011), 4 descendants of its own
- K233944: CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments (2024), 3 descendants of its own
- K020085: Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.X (2002), 3 descendants of its own

Source page: https://510kreport.com/device/K010515
Methodology: https://510kreport.com/methodology