510(k) K252699— CoAptix S System
Substantially EquivalentUniversity of Utah, Department of Orthopaedics
Summary
The CoAptix S System is an orthopedic soft-tissue fixation device — product code HWC covers suture anchors and related fixation hardware used in shoulder, knee, and other joint repairs. The "CoAptix S" naming pattern suggests a suture-based approach rather than a rigid anchor.
Orthopedic panel, Traditional 510(k). Notable applicant: this was filed by the University of Utah's Department of Orthopaedics directly rather than by a commercial medtech company — a university-held IP filing, which is less common on the device side than the drug side. It may reflect early-stage commercialization before license-out.
Based in Salt Lake City. Seven-month review clock. The fact that an academic group pursued 510(k) directly rather than licensing first suggests either a spin-out strategy or an intent to retain control through initial market entry.
Clearance details
- Applicant
- University of Utah, Department of Orthopaedics
- Product code
- Code HWC
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Adverse 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.