SYNTHES VECTRA SYSTEM— 510(k) K050451

Clearance details

Applicant

Synthes Spine Co.Lp

Product code

Code KWQ

Device class

Class 2

Regulation

21 CFR 888.3060

Advisory panel

Orthopedic

Date received

2005-02-22

Decision date

2005-03-24

Decision

Substantially Equivalent

Clearance type

Special

Location

West Chester, PA, US

• K261309 — Palisades Buttress Plate System2026-07-16
• K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
• K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
• K260570 — corra cervical plating system2026-04-22
• K260697 — VyPlate Anterior Cervical Plate System2026-03-27

• K121852 — SYNTHES ZERO-P VARIABLE ANGLE (VA)2012-07-25
• K112459 — SYNTHES ZERO-P2011-12-12
• K112068 — SYNTHES ZERO-P VARIABLE ANGLE (VA)2011-11-07
• K103320 — SYNTHES XRL2011-10-20
• K081568 — ANTEGRA-T2008-09-02

Death

8

Injury

1,212

Malfunction

1,233

Total

2,453

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2674-2014 — DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm part 04.613.257 lot 3693878 TI Vectra" Plate 4 Level / 64 mm part 04.613.364 lot 8143905Class II·Terminated·Synthes, Inc.·20140902
• Z-0781-2013 — Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).Class II·Terminated·Synthes USA HQ, Inc.·20120806
• Z-0782-2013 — Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).Class II·Terminated·Synthes USA HQ, Inc.·20120806

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050451.