| K-number | K260546 |
| Device name | Q Pedicle Instruments |
| Applicant | K2m, Inc. |
| Product code | OLO |
| Device class | Class II |
| Decision date | Mar 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The Q Pedicle Instruments are surgical instruments (including Q Taps and Q Screwdrivers) used as accessories to facilitate pedicle preparation and placement of VB Spine implants. They can function as navigated instruments compatible with Stryker's Spine Guidance Software or as non-navigated manual instruments, and are intended for use in the non-cervical spine in adult and pediatric (adolescent) patients.
The Q Pedicle Instruments are substantially equivalent to the predicate in intended use, indications for use, basic design, materials, fundamental scientific technology, and compatibility with navigation software (Stryker's Spine Guidance 5 Software and Mako Spine System). There is no change in design, device or navigation software compatibility, technological characteristics, principles of operation, manufacturing process, materials, sterilization, disinfection, or cleaning compared to the predicate.
Not stated in this summary.
The submission is a Special 510(k) for updates to company branding in product labeling only. Since the subject devices were previously verified and validated under predicates K240662 and K241517, and there are no changes to indications for use, design, software compatibility, technological characteristics, manufacturing, or materials, no additional testing is required. A risk assessment confirmed no new safety or effectiveness issues, supporting substantial equivalence.
View the full FDA submission: accessdata.fda.gov