Genesys Spine
Austin, TX, US
GENESYS SPINE appears in FDA device records in Austin, TX. FDA records list 31 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Genesys Spine carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Genesys Orthopedic Systems, LLCenforcement report, recall
- Genesys Orthopedics Systems, LLCenforcement report, recall
510(k) clearance history
FDA records hold 31 510(k) clearances for Genesys Spine between 2010 and 2025. The busiest year on record is 2016, with 5. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2011 | 2 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 2 |
| 2016 | 5 |
| 2017 | 3 |
| 2018 | 3 |
| 2019 | 4 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252322 | SIros-X System | OUR | Substantially Equivalent | |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | OVE | Substantially Equivalent | |
| K233595 | Genesys Spine Sacroiliac Joint Fusion System with Navigation | OLO | Substantially Equivalent | |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | OVE | Substantially Equivalent | |
| K220096 | Genesys Spine 3DP Lumbar Interbody System | MAX | Substantially Equivalent | |
| K191489 | Genesys Spine 3DP Cervical Interbody System | OVE | Substantially Equivalent | |
| K182987 | Genesys Spine 3DP Lumbar Interbody System | MAX | Substantially Equivalent | |
| K192678 | Genesys Spine Binary® Lumbar Plate System | KWQ | Substantially Equivalent | |
| K191748 | Genesys Spine Sacroiliac Joint Fusion System | OUR | Substantially Equivalent | |
| K192076 | Binary® Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K181295 | Genesys Spine AIS-C Cervical Stand-Alone System | OVE | Substantially Equivalent | |
| K173885 | Genesys Spine Binary Lumbar Plate System | KWQ | Substantially Equivalent | |
| K180056 | Genesys Spine AIS-C Cervical Anchored Interbody System | OVE | Substantially Equivalent | |
| K172469 | TiLock Modular Spinal System | NKB | Substantially Equivalent | |
| K171838 | TiLock2 Spinal System | NKB | Substantially Equivalent | |
| K171656 | Genesys Spine Apache Interbody Fusion System | MAX | Substantially Equivalent | |
| K161438 | Genesys Spine Apache® Anterior Lumbar Interbody Fusion System | MAX | Substantially Equivalent | |
| K161914 | Genesys Spine TiLock Cortical Spinal System | NKB | Substantially Equivalent | |
| K152099 | Genesys Spine Apache® Anchored Cervical Interbody Fusion System | OVE | Substantially Equivalent | |
| K161404 | Genesys Spine Apache® Lateral Lumbar Interbody Fusion System | MAX | Substantially Equivalent | |
| K153123 | Genesys Spine Apache Interbody Fusion System | MAX | Substantially Equivalent | |
| K152039 | Genesys Spine TiLock2 Spinal System | NKB | Substantially Equivalent | |
| K150812 | Genesys Spine Apache Cervical Interbody Fusion System | ODP | Substantially Equivalent | |
| K133245 | GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM | KWQ | Substantially Equivalent | |
| K133911 | GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K130913 | GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM | MAX | Substantially Equivalent | |
| K130317 | GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM | ODP | Substantially Equivalent | |
| K111132 | GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K103671 | GENESYS SPINE TILOCK SYSTEM | NKB | Substantially Equivalent | |
| K103034 | GENESYS SPINE INTERBODY FUSION SYSTEM | MAX | Substantially Equivalent | |
| K100757 | TILOCK PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008455034 | 3008455034 | GENESYS SPINE | 1250 S Capital of TX Highway, Austin, TX 78746 US | 2026 | and 16 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HXWBender
- KTZCaliper
- HXZCutter, Wire
- HWBExtractor
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- HXLMallet
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HXIPasser, Wire, Orthopedic
- HTCPliers, Surgical
- HXBProbe
- HTXRongeur
- OURSacroiliac Joint Fixation
- HXXScrewdriver
- MQPSpinal Vertebral Body Replacement Device
- HWXTap, Bone
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off. | Class II | Terminated | |
| Z-2677-2014 | Circular 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 spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion). | The 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. | Class II | Terminated | |
| Z-0921-2013 | 3.75mm 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. | Class II | Terminated | |
| Z-1698-2012 | Transforminal 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 threading the implant onto the tip of the inserter shaft. Once the implant is seated within the vertebrae the inserter is removed by unthreading the inserter from the implant. | The inserters have the potential to break. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain