# K050451: Synthes Vectra System

- Pathway: 510(k) (Special)
- Applicant: Synthes Spine Co.Lp
- Decided: Mar 24, 2005 after 30 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K031276 (2003). 2 ancestors in all.
84 later devices descend from it; 8 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033844: Synthes Anterior Cervical Compression System, Synthes (Usa) (2004) Summary page 1.

## Most influential descendants
- K051665: Synthes Vectra-T System (2005), 49 descendants of its own
- K112068: Synthes Zero-P Variable Angle (VA) (2011), 33 descendants of its own
- K121852: Synthes Zero-P Variable Angle (VA) (2012), 30 descendants of its own
- K071667: Synthes Vectra-One System (2007), 26 descendants of its own
- K131429: Reliance Cervical Ibf System (2013), 24 descendants of its own

## Recalls of this device
- Sep 2, 2014 · Class II · Z-2674-2014: DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Plates, which is a part of the DePuy Synthes Vectra Anterior Cervical Plate Family of Systems. The Vectra
- Aug 6, 2012 · Class II · Z-0782-2013: Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.
- Aug 6, 2012 · Class II · Z-0781-2013: Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.

## Indications for use
Synthes VECTRA System is intended for anterior plate and screw fixation of the cervical spine (C2-C7). Synthes VECTRA System is ihdicated for the following: * Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) * Spondylolisthesis * Trauma (i.e., fractures or dislocations) * Spinal Stenosis * Tumors (primary and metastatic) * Failed previous fusions * Pseudoarthrosis * Deformity (i.e., scoliosis, kyphosis, and/or lordosis) Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K050451
Methodology: https://510kreport.com/methodology