Stabiliz Orthopaedics, Inc. · Class II · Cleared Mar 23, 2026
| K-number | K260112 |
| Device name | QuikFix External Fixator: Knee-Spanning Pack |
| Applicant | Stabiliz Orthopaedics, Inc. |
| Product code | KTT |
| Device class | Class II |
| Decision date | Mar 23, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The QuikFix External Fixator: Knee-Spanning Pack is an external fixation system for treating long bone fractures of the leg. It is intended for temporary stabilization of acute fractures with soft tissue injuries, polytrauma, post-arthroplasty removal, non-unions, and intra-operative reduction assistance. The device is for non-weight bearing patients only and components are single-use and MR-conditional.
The subject device and predicate devices have the same intended use, similar technological characteristics, and are made of similar materials. Both are packaged in similar materials and sterilized using similar methods. The QuikFix External Fixator: Knee-Spanning Pack includes fixation pins, clamps and rods designed to build a fixator construct.
Axial/Torsional Load to Bar and Pin Test per ASTM F1541 Annex 4; Dynamic Construct Testing; MRI Safety Testing per ASTM F2052-21 and ASTM F2213-17.
The subject device and predicate devices have the same intended use and similar technological characteristics. All performance testing conducted for the QuikFix External Fixator: Knee-Spanning Pack met acceptance criteria or were otherwise considered acceptable. The device is substantially equivalent to the predicate devices for the intended use.
View the full FDA submission: accessdata.fda.gov