Atlas FDA

MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU

FDA 510(k) clearance K860133 · decided 1986-03-10

Clearance details

K-number
K860133
Device name
MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
Applicant
Depuy, Inc.
Decision
Substantially Equivalent for Some Indications
Date received
1986-01-14
Decision date
1986-03-10
Days to decision
55 days
Clearance type
Traditional
Product code
HRY
Device class
2
Regulation number
888.3530
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, 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
ATTUNE™ Revision Rotating Platform (RP) Knee System (P830055/S346)Depuy, Inc.2025-12-18
LCS Total Knee System (P830055/S355)Depuy, Inc.2025-12-15
LCS® Total Knee System (P830055/S354)Depuy, Inc.2025-12-11
LCS® Total Knee System (P830055/S353)Depuy, Inc.2025-12-09
LCS® Total Knee System (P830055/S352)Depuy, Inc.2025-11-26
LCS® Total Knee System (P830055/S350)Depuy, Inc.2025-09-26
LCS® Total Knee System (P830055/S349)Depuy, Inc.2025-09-09
LCS Total Knee System (P830055/S348)Depuy, Inc.2025-08-29