Atlas FDA

UNITY TOATAL KNEE SYSTEM

FDA 510(k) clearance K113060 · decided 2012-09-10

Clearance details

K-number
K113060
Device name
UNITY TOATAL KNEE SYSTEM
Applicant
Corin USA
Decision
Substantially Equivalent
Date received
2011-10-14
Decision date
2012-09-10
Days to decision
332 days
Clearance type
Traditional
Product code
JWH
Device class
2
Regulation number
888.3560
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Tampa, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arth recall (Z-0213-2024)Corin Ltd2023-11-02
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthropl recall (Z-0214-2024)Corin Ltd2023-11-02
Unity Total Knee System. Used for knee prosthesis in total knee replacement recall (Z-0273-2023)Corin Ltd2022-11-21

PMA approvals by this applicant

RecordFirmDate
Cormet Hip Resurfacing System (P050016/S012)Corin USA2020-07-17
CORMET HIP RESURFACING SYSTEM (P050016/S011)Corin USA2016-12-21
CORMET HIP RESURFACING SYSTEM (P050016/S010)Corin USA2014-04-03
CORMET HIP RESURFACING SYSTEM (P050016/S009)Corin USA2013-03-22
CORMET HIP RESURFACING SYSTEM (P050016/S008)Corin USA2011-11-10
CORMET HIP RESURFACING SYSTEM (P050016/S007)Corin USA2011-01-13
CORMET HIP RESURFACING SYSTEM (P050016/S006)Corin USA2009-12-31
CORMET HIP RESURFACING SYSTEM (P050016/S005)Corin USA2009-12-03