# K071667: Synthes Vectra-One System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: Nov 30, 2007 after 164 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: 3 generations back to K031276 (2003). 7 ancestors in all.
26 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926453: Synthes (U.S.a.) Anterior Cervical Vertebrae Plate, Synthes (Usa) (1993) Summary page 1.
- K050451: Synthes Vectra System, Synthes Spine Co.Lp (2005) Summary page 1.
- K792352: Synthes Cervical Vertabrae Plates, DePuy Synthes (1979) Summary page 1.
- K042544: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 1.

## Most influential descendants
- K130030: Zavation Cervical Plate System (2013), 15 descendants of its own
- K143576: Exactech Ambassador (2015), 7 descendants of its own
- K172104: Ozark (tm) Cervical Plate System (2017), 5 descendants of its own
- K190227: Boomerang™ Anterior Cervical Plate System (2019), 4 descendants of its own
- K182473: PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems (2018), 4 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
The Vectra-One System is intended for anterior plate and screw fixation of the cervical spine (C2-C7) for the following indications:: · 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 * Pseudarthrosis · Deformity (i.e., kyphosis, lordosis and/or scoliosis) 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/K071667
Methodology: https://510kreport.com/methodology