Atlas FDA

MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS

FDA 510(k) clearance K001451 · decided 2000-05-18

Clearance details

K-number
K001451
Device name
MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
Applicant
DePuy Orthopaedics, Inc.
Decision
Substantially Equivalent
Date received
2000-05-09
Decision date
2000-05-18
Days to decision
9 days
Clearance type
Special
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
Ceramax Ceramic Hip System (P070026/S123)DePuy Orthopaedics, Inc.2025-12-09
CERAMAX CERAMIC HIP SYSTEM (P070026/S121)DePuy Orthopaedics, Inc.2025-08-05
CERAMAX CERAMIC HIP SYSTEM (P070026/S122)DePuy Orthopaedics, Inc.2025-08-01
CERAMAX® ceramic total hip system (P070026/S120)DePuy Orthopaedics, Inc.2025-06-24
CERAMAX CERAMIC HIP SYSTEM (P070026/S119)DePuy Orthopaedics, Inc.2025-04-04
DePuy Ceramax Ceramic Total Hip System (P070026/S114)DePuy Orthopaedics, Inc.2025-03-19
Ceramax Ceramic Hip System (P070026/S117)DePuy Orthopaedics, Inc.2025-02-21
Ceramax® Ceramic Total Hip System (P070026/S116)DePuy Orthopaedics, Inc.2025-02-11