CoAptix S System— 510(k) K252699
Substantially EquivalentUniversity of Utah, Department of Orthopaedics
FDA 510(k) clearance K252699 for CoAptix S System, Substantially Equivalent on 2026-04-10. Applicant: University of Utah, Department of Orthopaedics. Device class: 2.
Summary
The CoAptix S System is filed under HWC, bone fixation screws. The record doesn't describe the screw design or the anatomy it's meant for.
Class II, 21 CFR 888.3040. The Orthopedic panel reviewed it as a Traditional 510(k).
The applicant is unusual for a 510(k): the University of Utah's Department of Orthopaedics, filing from Salt Lake City. Universities rarely hold device clearances directly. Most academic inventions reach FDA through a licensee or a spinout company. Review took 226 days (August 27, 2025 to April 10, 2026).
Clearance details
- Applicant
- University of Utah, Department of Orthopaedics
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code HWC
view allMore clearances from University of Utah, Department of Orthopaedics
view allAdverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.