Genius Total Knee System— 510(k) K170613
Substantially EquivalentSignature Orthopaedics Pty, Ltd.
FDA 510(k) clearance K170613 for Genius Total Knee System, Substantially Equivalent on 2017-07-17. Applicant: Signature Orthopaedics Pty, Ltd.. Device class: 2.
Clearance details
- Applicant
- Signature Orthopaedics Pty, Ltd.
- 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
- Lane Cove West, AU
Recent devices under product code JWH
view allMore clearances from Signature Orthopaedics Pty, Ltd.
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 K170613
K-number listed on FDA's recall record- Z-0833-2019 — Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
- Z-0834-2019 — Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170613.
Data sourced from openFDA. This site is unofficial and independent of the FDA.