Atlas FDA

SIGMA High Performance (HP) Partial Knee System

FDA 510(k) clearance K193549 · decided 2020-04-16

Clearance details

K-number
K193549
Device name
SIGMA High Performance (HP) Partial Knee System
Applicant
Depuy Ireland UC
Decision
Substantially Equivalent
Date received
2019-12-20
Decision date
2020-04-16
Days to decision
118 days
Clearance type
Traditional
Product code
HRY
Device class
2
Regulation number
888.3530
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Ringaskiddy, IE
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
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
TRIATHLON PKR SYSTEM (K071881)Howmedica Osteonics Corp.2007-10-09

Recalls involving this device

No recalls on record reference this clearance.