# K030866: Synthes Anterior CSLP System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 18, 2003 after 30 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
339 later devices descend from it; 42 cite it directly.
0 of 340 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K040721: Assure Anterior Cervical Plate System (2004), 178 descendants of its own
- K070775: Modification to: Providence Anterior Cervical Plate System (2007), 177 descendants of its own
- K081391: Vip Anterior Cervical Plate System (2008), 171 descendants of its own
- K142218: Coalition AGX Plate and Coalition AGX Spacer (2015), 155 descendants of its own
- K152022: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer (2017), 149 descendants of its own

## Indications for use
The Synthes Anterior CSLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: 1. Spondylolisthesis 2. Fracture 3. Spinal stenosis 4. Tumor 5. Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).

Source page: https://510kreport.com/device/K030866
Methodology: https://510kreport.com/methodology