GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM— 510(k) K133245

Name: FDA 510(k) clearance K133245
Creator: U.S. Food and Drug Administration
Published: 2014-10-08

Substantially Equivalent

Genesys Spine

FDA 510(k) clearance K133245 for GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM, Substantially Equivalent on 2014-10-08. Applicant: Genesys Spine. Device class: 2.

Clearance details

Applicant: Genesys Spine
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2013-10-22
Decision date: 2014-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWQ

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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

More clearances from Genesys Spine

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K252322 — SIros-X System2025-10-22
K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System2025-02-07
K233595 — Genesys Spine Sacroiliac Joint Fusion System with Navigation2024-03-29
K233594 — Genesys Spine 3DP AIS-C II Cervical Interbody System2023-12-13
K220096 — Genesys Spine 3DP Lumbar Interbody System2022-03-09

Adverse events under product code KWQ

product code KWQ

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 →

Recalls naming K133245

K-number listed on FDA's recall record

Z-0040-2018 — Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.Class II·Terminated·Genesys Orthopedics Systems, LLC·20151105

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133245.

Data sourced from openFDA. This site is unofficial and independent of the FDA.