# K971883: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Oct 16, 1997 after 147 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
Longest line of descent: 1 generation back to K926453 (1993). 2 ancestors in all.
531 later devices descend from it; 16 cite it directly.
1 of 534 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 1.
- K926453: Synthes (U.S.a.) Anterior Cervical Vertebrae Plate, Synthes (Usa) (1993) Summary page 1.

## Most influential descendants
- K103287: Synthes 6.0 Cocr and CPT TI-3 Rods (2011), 348 descendants of its own
- K113395: Revere 4.5 Stabilization System (2012), 260 descendants of its own
- K122226: Revere Stabilization System (2012), 225 descendants of its own
- K124058: Creo Stabilization System (2013), 172 descendants of its own
- K143633: CREO Stabilization System (2015), 158 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

## Indications for use
The Small Stature Anterior Cervical Vertebrae Plate System (as part of the Anterior Cervical Vertebrae Plate 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

Source page: https://510kreport.com/device/K971883
Methodology: https://510kreport.com/methodology