| K-number | K260411 |
| Device name | PC Fix System |
| Applicant | Chest Wall Innovations, Inc. |
| Product code | HRS |
| Device class | Class II |
| Decision date | Apr 24, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The PC Fix System is a rib fixation device consisting of titanium and PEEK plates with a post-and-cap locking construct. It is indicated for fixation, stabilization, and fusion of rib fractures and osteotomies in normal and osteoporotic bone. The system includes fixation plates with anchoring teeth, locking posts, locking caps, and reusable stainless-steel instruments.
The device features design and technological characteristics equivalent to the predicate device (Zimmer Biomet RibFix Advantage System) and reference devices. Materials are identical to those in the predicate and reference devices. The system uses titanium and PEEK materials for implants and medical-grade stainless steel for reusable instruments conforming to ASTM F899.
Static and dynamic testing per ASTM F382 (Standard Specification and Test Method for Metallic Bone Plates) and ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, adapted for rib fixation). Reusable instruments conform to ASTM F899.
The PC Fix System is substantially equivalent because it has identical indications for use, equivalent design and technological characteristics, identical materials, and performance data confirming that differences do not raise new safety or effectiveness questions compared to the predicate and reference devices. All mechanical testing satisfied applicable acceptance criteria.
View the full FDA submission: accessdata.fda.gov