Atlas FDA

PLATFORM TCCK TOTAL KNEE

FDA 510(k) clearance K790762 · decided 1979-05-14

Clearance details

K-number
K790762
Device name
PLATFORM TCCK TOTAL KNEE
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
1979-04-17
Decision date
1979-05-14
Days to decision
27 days
Clearance type
Traditional
Product code
HRY
Device class
2
Regulation number
888.3530
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
SIGMA High Performance (HP) Partial Knee System (K193549)Depuy Ireland UC2020-04-16
NanoOrtho NanoKnee® System (K190633)Nanoortho, LLC2019-12-20
MPO Total Knee Systems MR Labeling (K152631)Microport Orthopedics, Inc.2016-03-23
RESTORIS POROUS PARTIAL KNEE SYSTEM (K150410)Mako Surgical Corporation2015-03-20
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) (K133940)Biomet UK, Ltd.2014-03-28
UNIVATION (K131167)Aesculap Implant Systems, LLC2013-10-17
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM (K122277)Biomet Manufacturing Corp2012-10-22
SIGNATURE PLANNER / SIGNATURE GUIDES (K110415)Materialise NV2011-05-16
EVOLUTION UNICONDYLAR KNEE SYSTEM (K100973)Wrightmedicaltechnologyinc2010-08-10
STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION (K082567)Howmedica Osteonics Corp.2008-10-03
UNIVATION UNICONDYLAR KNEE SYSTEM (K081293)Aesculap Implant Systems, Inc.2008-09-22
UNICOMPARTMENTAL KNEE (K072704)Valpo Orthopedic Technology, Inc.2008-02-19

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009)Biomet, Inc.2011-02-11
C2A-TAPER ACETABULAR SYSTEM (P050009/S004)Biomet, Inc.2009-04-17
C2A TAPER ACETABULAR SYSTEM (P050009/S007)Biomet, Inc.2009-03-13
C2-A TAPER ACETABULAR SYSTEM (P050009/S005)Biomet, Inc.2007-11-30
C2A-TAPER ACETABULAR SYSTEM (P050009/S002)Biomet, Inc.2006-06-16
C2A-TAPER ACETABULAR SYSTEM (P050009/S001)Biomet, Inc.2006-02-01
C2 A-TAPER ACETABULAR SYSTEM (P050009)Biomet, Inc.2005-12-16