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Data / Medical devices / United States / Genesys Spine

Genesys Spine: FDA-registered device maker in Austin, TX, United States, 29 510(k) clearances

Genesys Spine is registered with the FDA (registration 3008455034) in Austin, TX, United States. It lists 26 device types. The FDA files 29 510(k) clearances under its listings, the newest dated October 22, 2025. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Genesys Spine
FDA registration number
3008455034
Address
1250 S Capital of TX Highway Building Three, Suite 600, Austin, TX, United States, 78746
Owner or operator
Genesys Spine (10033848)
Roles
Manufacturer, Specification developer
First device listed
October 12, 2010
Registered through
2026
Brand names listed
AIS-C, AIS-C Cervical Anchored Interbody System, AIS-C Stand-Alone System, Apache, Apache Anchored Cervical Interbody Fusion System, Apache Cervical Stand-Alone System, Apache Hyperlordotic ALIF, Apache IBFD / VBR and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Manufactureraccessdata.fda.gov
AwlHWJ1Manufactureraccessdata.fda.gov
BenderHXW1Manufactureraccessdata.fda.gov
CaliperKTZ1Manufactureraccessdata.fda.gov
Cutter, WireHXZ1Manufactureraccessdata.fda.gov
ExtractorHWB1Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufacturer, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Manufactureraccessdata.fda.gov
MalletHXL1Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Manufactureraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Manufactureraccessdata.fda.gov
Pliers, SurgicalHTC1Manufactureraccessdata.fda.gov
ProbeHXB1Manufactureraccessdata.fda.gov
RongeurHTX1Manufactureraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Manufactureraccessdata.fda.gov
Tap, BoneHWX1Manufactureraccessdata.fda.gov
TemplateHWT1Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufactureraccessdata.fda.gov
WrenchHXC1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 22, 2025K252322SIros-X SystemOURSubstantially EquivalentGenesys Spineaccessdata.fda.gov
February 7, 2025K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemOVESubstantially EquivalentGenesys Spineaccessdata.fda.gov
March 29, 2024K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationOLOSubstantially EquivalentGenesys Spineaccessdata.fda.gov
December 13, 2023K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemOVESubstantially EquivalentGenesys Spineaccessdata.fda.gov
March 9, 2022K220096Genesys Spine 3DP Lumbar Interbody SystemMAXSubstantially EquivalentGenesys Spineaccessdata.fda.gov
January 8, 2020K191489Genesys Spine 3DP Cervical Interbody SystemOVESubstantially EquivalentGenesys Spineaccessdata.fda.gov
December 12, 2019K182987Genesys Spine 3DP Lumbar Interbody SystemMAXSubstantially EquivalentGenesys Spineaccessdata.fda.gov
October 24, 2019K192678Genesys Spine Binary® Lumbar Plate SystemKWQSubstantially EquivalentGenesys Spineaccessdata.fda.gov
September 26, 2019K191748Genesys Spine Sacroiliac Joint Fusion SystemOURSubstantially EquivalentGenesys Spineaccessdata.fda.gov
August 29, 2019K192076Binary® Anterior Cervical Plate SystemKWQSubstantially EquivalentGenesys Spineaccessdata.fda.gov
August 29, 2018K181295Genesys Spine AIS-C Cervical Stand-Alone SystemOVESubstantially EquivalentGenesys Spineaccessdata.fda.gov
April 3, 2018K173885Genesys Spine Binary Lumbar Plate SystemKWQSubstantially EquivalentGenesys Spineaccessdata.fda.gov
March 28, 2018K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemOVESubstantially EquivalentGenesys Spineaccessdata.fda.gov
November 30, 2017K172469TiLock Modular Spinal SystemNKBSubstantially EquivalentGenesys Spineaccessdata.fda.gov
July 19, 2017K171838TiLock2 Spinal SystemNKBSubstantially EquivalentGenesys Spineaccessdata.fda.gov
July 13, 2017K171656Genesys Spine Apache Interbody Fusion SystemMAXSubstantially EquivalentGenesys Spineaccessdata.fda.gov
November 8, 2016K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemMAXSubstantially EquivalentGenesys Spineaccessdata.fda.gov
August 9, 2016K161914Genesys Spine TiLock Cortical Spinal SystemNKBSubstantially EquivalentGenesys Spineaccessdata.fda.gov
July 28, 2016K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemOVESubstantially EquivalentGenesys Spineaccessdata.fda.gov
April 26, 2016K153123Genesys Spine Apache Interbody Fusion SystemMAXSubstantially EquivalentGenesys Spineaccessdata.fda.gov
October 28, 2015K152039Genesys Spine TiLock2 Spinal SystemNKBSubstantially EquivalentGenesys Spineaccessdata.fda.gov
September 3, 2015K150812Genesys Spine Apache Cervical Interbody Fusion SystemODPSubstantially EquivalentGenesys Spineaccessdata.fda.gov
October 8, 2014K133245GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEMKWQSubstantially EquivalentGenesys Spineaccessdata.fda.gov
September 3, 2014K133911GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEMKWQSubstantially EquivalentGenesys Spineaccessdata.fda.gov
December 11, 2013K130317GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEMODPSubstantially EquivalentGenesys Spineaccessdata.fda.gov
December 9, 2011K111132GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially EquivalentGenesys Spineaccessdata.fda.gov
July 21, 2011K103671GENESYS SPINE TILOCK SYSTEMNKBSubstantially EquivalentGenesys Spineaccessdata.fda.gov
December 10, 2010K103034GENESYS SPINE INTERBODY FUSION SYSTEMMAXSubstantially EquivalentGenesys Spineaccessdata.fda.gov
July 1, 2010K100757TILOCK PEDICLE SCREW SYSTEMNKBSubstantially EquivalentGenesys Spineaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
November 5, 201578181Class IITerminatedGenesys 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. IUnanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.accessdata.fda.gov
April 2, 201467900Class IITerminatedCircular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinalThe recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy.accessdata.fda.gov
February 20, 201364421Class IITerminated3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.accessdata.fda.gov
August 24, 201161623Not yet classifiedTerminatedTransforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System. The TLIF PEEK inserter is used to introduce the TLIF PEEK implant into the patients spine by threadingThe inserters have the potential to break.accessdata.fda.gov

Compare with other makers

Updated October 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.