# K000536: Synthes Anterior CSLP System

- Pathway: 510(k) (Special)
- Applicant: Synthes Spine
- Decided: Mar 15, 2000 after 28 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
297 later devices descend from it; 40 cite it directly.
0 of 298 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
- K131025: Archon Anterior Cervical Plate System (2013), 97 descendants of its own
- K161442: NuVasive® CoRoent® Small Interlock™ System (2016), 94 descendants of its own
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS (2017), 83 descendants of its own
- K070681: Next Generation Anterior Cervical Plating System (2007), 62 descendants of its own
- K102820: Appliance, Fixation, Spinal Intervertebral Body (2010), 38 descendants of its own

## Recalls of this device
- Jan 6, 2016 · Class II · Z-1524-2016: DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part of the Cervical Spine Locking Plate (CSLP) System du

Source page: https://510kreport.com/device/K000536
Methodology: https://510kreport.com/methodology