Atlas FDA

REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT

FDA 510(k) clearance K061681 · decided 2006-10-19

Clearance details

K-number
K061681
Device name
REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT
Applicant
Biomet Manufacturing Corp
Decision
Substantially Equivalent
Date received
2006-06-15
Decision date
2006-10-19
Days to decision
126 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.

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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
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Oxford™ Partial Knee System (P010014/S117)Biomet Manufacturing Corp2026-07-13
Oxford Partial Knee System; Cementless Oxford™Partial Knee System (P010014/S112)Biomet Manufacturing Corp2026-05-27
Oxford® Partial Knee System (P010014/S116)Biomet Manufacturing Corp2026-05-12
Oxford® Partial Knee System (P010014/S115)Biomet Manufacturing Corp2026-04-20
Oxford Cementless Partial Knee System (P010014/S114)Biomet Manufacturing Corp2026-03-06
Oxford Partial Knee System (P010014/S113)Biomet Manufacturing Corp2026-01-16
Oxford™ Knee System (P010014/S111)Biomet Manufacturing Corp2025-08-07
Oxford Partial Knee System (P010014/S109)Biomet Manufacturing Corp2025-08-07