Invictus Bands System
FDA 510(k) K253615 · Alphatec Spine, Inc.
510(k) numberK253615
Submission
- Device name
- Invictus Bands System
- Applicant
- Alphatec Spine, Inc.
Carlsbad, CA, US - Received
- November 18, 2025
- Decision date
- March 25, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWI – Bone Fixation Cerclage, Sublaminar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
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| K261374 | LigaPASS SystemOWI · Special | Medicrea International S.A.S | 05/27/2026SE |
| K222097 | OLYMPIC Deformity Band SystemOWI · Traditional | Astura Medical | 05/04/2023SE |
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| K213659 | LigaPASS 2.0 Ligament Augmentation SystemOWI · Traditional | Medicrea International SA | 05/24/2022SE |
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| K201240 | Mariner Cap SystemOWI · Traditional | SeaSpine Orthopedics Corporation | 08/05/2020SE |
| K200281 | The Gecko Spinal SystemOWI · Traditional | Ortho Development Corporation | 03/31/2020SE |
| K200097 | Response BandLoc Spinal FixationOWI · Traditional | OrthoPediatrics Corp. | 03/16/2020SE |
| K191217 | Jazz PFOWI · Traditional | Implanet, S.A. | 08/02/2019SE |
| K190289 | Karma® Fixation SystemOWI · Traditional | Spinal Elements, Inc. | 04/03/2019SE |
More from Spinal Elements, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional | 07/14/2026SE |
| K253216 | IntraOp Alignment System; CONTOUR3D Bending SystemSIN · Traditional | 06/25/2026SE |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…OLO · Traditional | 02/19/2026SE |
| K252842 | SafeOp 3: Neural Informatix SystemGWF · Traditional | 01/11/2026SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | 09/03/2025SE |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQ · Traditional | 08/28/2025SE |
| K251080 | IdentiTi II Cervical Interbody SystemODP · Traditional | 07/03/2025SE |
| K243461 | Calibrate Interbody Systems · Traditional | 03/04/2025SE |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…MAX · Traditional | 02/03/2025SE |
| K242364 | IdentiTi II Interbody SystemMAX · Traditional | 10/04/2024SE |
Questions and answers
When was Invictus Bands System cleared by the FDA?
Invictus Bands System (K253615) received a 510(k) decision of Substantially Equivalent on March 25, 2026, 127 days after the submission was received.
What is the product code of K253615?
The FDA product code is OWI – Bone Fixation Cerclage, Sublaminar, a Class II (moderate risk) device regulated under 21 CFR 888.3010.