| K-number | K252873 |
| Device name | Q Interbody Instruments |
| Applicant | K2m, Inc. |
| Product code | OLO |
| Device class | Class II |
| Decision date | Feb 6, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The Q Interbody Instruments are surgical instruments (inserters, trials, and calibration devices) designed to facilitate preparation and placement of VB Spine interbody implants. They function as accessories to Stryker's Spine Guidance System and can operate as navigated instruments using navigation software or as non-navigated manual instruments.
The Q Interbody Instruments are substantially equivalent to the Q Pedicle Instruments predicate in intended use, indications, basic design, materials, fundamental scientific technology, and compatibility with navigation software. Both are stereotaxic instruments designed for use with Stryker's Spine Guidance System.
System accuracy verification per ASTM F2554; biocompatibility verification per ISO 10993-1:2018 and FDA guidance; sterilization validation of reusable devices per ISO 17665-1 and FDA guidance on reprocessing medical devices.
The Q Interbody Instruments perform as intended and are substantially equivalent to the Q Pedicle Instruments predicate device regarding intended use, indications, design, principles of operation, technology, materials, performance, and navigation software compatibility. Verification and validation testing confirmed no new or different issues of safety and effectiveness, demonstrating the devices are at least as safe and effective as the predicate.
View the full FDA submission: accessdata.fda.gov