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Sign in to claim this brandGenesys Orthopedics Systems LLC
US
Last updated May 24, 2026
What Genesys Orthopedics Systems LLC makes
Genesys Orthopedics Systems LLC manufactures spinal fixation and fusion devices, including metallic spinal interbody cages, vertebral body prostheses, and interspinous decompression spacers for lumbar and cervical applications. Their portfolio also includes non-bioabsorbable spinal fixation plates, orthopaedic bone screws, and trial implants for spinal procedures. The company produces both non-sterile and sterile-free systems for internal spinal stabilization and joint fusion, such as the 3DP Lumbar and Cervical Interbody Systems and the Sacroiliac Joint Fusion System.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are designed for spinal and orthopedic applications and comply with relevant U.S. regulatory requirements. The manufacturer operates within the United States, adhering to applicable medical device regulations
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Genesys Orthopedics Systems LLC manufacture?
Genesys Orthopedics Systems LLC specializes in spinal and orthopedic devices primarily used for internal spinal fixation and joint fusion. Their portfolio includes metallic spinal interbody fusion cages, vertebral body prostheses, interspinous decompression spacers (for lumbar applications), spinal fixation plates, orthopedic bone screws, and trial implants for spinal procedures. Examples of their products are the 3DP Lumbar and Cervical Interbody Systems, the Sacroiliac Joint Fusion System, and the Apache and TiLock systems, which are designed for stabilization and fusion in spinal surgeries.
Where is Genesys Orthopedics Systems LLC based?
Genesys Orthopedics Systems LLC is based in the United States. As a U.S.-based manufacturer, their devices are subject to and comply with applicable U.S. medical device regulations, including those governing classification, labeling, and post-market surveillance.
Are Genesys Orthopedics Systems LLC’s devices listed in any regulatory registries?
Yes, Genesys Orthopedics Systems LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and clinical purposes. Listing in this database is a requirement for devices marketed in the U.S.
How are Genesys Orthopedics Systems LLC’s devices classified by the FDA?
Genesys Orthopedics Systems LLC’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may have fewer regulatory controls, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part involved, such as spinal fixation or joint fusion.
What distinguishes Genesys Orthopedics Systems LLC’s non-sterile devices from sterile ones?
Genesys Orthopedics Systems LLC produces both non-sterile and sterile-free systems, meaning their devices are not pre-sterilized for direct patient use. Non-sterile devices are typically packaged for sterilization by the healthcare facility or surgeon before implantation, allowing for customization of sterilization methods (e.g., autoclaving or ethylene oxide) based on clinical needs. This approach is common for devices like spinal fixation systems or bone screws, where sterilization protocols may vary by facility.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- genesysspine.com
- —
- —
- [email protected]
- Phone
- 512-381-7070
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 017921066
Catalogue (5558)
Page 1 of 112| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 3DP Lumbar Interbody System | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
| 3DP Lumbar Interbody System | 1 | FDA UDI | Class II | Active |
| Sacroiliac Joint Fusion System | 1 | FDA UDI | Class II | Active |
| 3DP Lumbar Interbody System | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
| 3DP Cervical Interbody System | 1 | FDA UDI | Class II | Active |
| Binary | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
| 3DP Lumbar Interbody System | 1 | FDA UDI | Class II | Active |
| 3DP Cervical Interbody System | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
| 3DP Lumbar Interbody System | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| Sacroiliac Joint Fusion System | 1 | FDA UDI | Class II | Active |
| Stasys-C Standalone PEEK | 1 | FDA UDI | Class II | Active |
| 3DP Lumbar Interbody System | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| 3DP Lumbar Interbody System | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| 3DP Lumbar Interbody System | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| Lumbar Plate | 1 | FDA UDI | Class II | Active |
| 3DP Lumbar Interbody System | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| TILock | 1 | FDA UDI | Class II | Active |
| 3DP Lumbar Interbody System | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
| AIS-C Standalone System | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| Lumbar Plate | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
| TiLock | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
| Apache | 1 | FDA UDI | Class II | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Genesys Orthopedics Systems LLC has one FDA recall record initiated on 2014-04-02, which is marked as terminated. The recall was prompted by a notification from the supplier, MK Precision, indicating that a portion (less than 20%) of Circular Lock Screws in lot 11406 were manufactured with stainless steel in the center post instead of the required titanium alloy.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 2, 2014 | Z-2677-2014 | — | terminated | 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. |