iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System— 510(k) K193105
Substantially EquivalentConformis, Inc.
FDA 510(k) clearance K193105 for iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System, Substantially Equivalent on 2020-03-13. Applicant: Conformis, Inc.. Device class: 2.
Clearance details
- Applicant
- Conformis, Inc.
- 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
- Billerica, MA, US
Recent devices under product code JWH
view allMore clearances from Conformis, Inc.
view all- K232426 — Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
- K223316 — Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System
- K230846 — iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System
- K231233 — Identity Imprint CR KRS and Identity Imprint PS KRS
- K231178 — ACTERA hip system
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.