UNITY TOATAL KNEE SYSTEM— 510(k) K113060
Substantially EquivalentCorin USA
FDA 510(k) clearance K113060 for UNITY TOATAL KNEE SYSTEM, Substantially Equivalent on 2012-09-10. Applicant: Corin USA. Device class: 2.
Clearance details
- Applicant
- Corin USA
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampa, FL, US
Recent devices under product code JWH
view allMore clearances from Corin USA
view allAdverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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 →
Recalls naming K113060
K-number listed on FDA's recall record- Z-0213-2024 — Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
- Z-0214-2024 — Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
- Z-0273-2023 — Unity Total Knee System. Used for knee prosthesis in total knee replacement
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113060.
Data sourced from openFDA. This site is unofficial and independent of the FDA.