IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM— 510(k) K132640
Substantially EquivalentConformis, Inc.
FDA 510(k) clearance K132640 for IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM, Substantially Equivalent on 2013-12-05. Applicant: Conformis, Inc.. Device class: 2.
Clearance details
- Applicant
- Conformis, Inc.
- Product code
- Code HSX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3520
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code HSX
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 HSX
product code HSX- Injury
- 1,003
- Other
- 1
- Total
- 1,004
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 K132640
K-number listed on FDA's recall record- Z-0138-2016 — ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
- Z-0139-2016 — ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)
- Z-0140-2016 — ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132640.
Data sourced from openFDA. This site is unofficial and independent of the FDA.