Atlas FDA

OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM

FDA 510(k) clearance K122277 · decided 2012-10-22

Clearance details

K-number
K122277
Device name
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
Applicant
Biomet Manufacturing Corp
Decision
Substantially Equivalent
Date received
2012-07-30
Decision date
2012-10-22
Days to decision
84 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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UNIVATION UNICONDYLAR KNEE SYSTEM (K081293)Aesculap Implant Systems, Inc.2008-09-22
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Recalls involving this device

RecordFirmDate
REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / recall (Z-1695-2013)Biomet, Inc.2013-07-11
REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 ARCOM UHMWPE / recall (Z-1696-2013)Biomet, Inc.2013-07-11
REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5 ARCOM UHMWPE / recall (Z-1697-2013)Biomet, Inc.2013-07-11
REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE / recall (Z-1698-2013)Biomet, Inc.2013-07-11
REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / recall (Z-1699-2013)Biomet, Inc.2013-07-11
REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3 ARCOM UHMWPE / recall (Z-1700-2013)Biomet, Inc.2013-07-11
REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 ARCOM UHMWPE / recall (Z-1701-2013)Biomet, Inc.2013-07-11
REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / recall (Z-1702-2013)Biomet, Inc.2013-07-11
REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM UHMWPE / C recall (Z-1703-2013)Biomet, Inc.2013-07-11
REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / recall (Z-1704-2013)Biomet, Inc.2013-07-11
REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3 ARCOM UHMWPE / recall (Z-1705-2013)Biomet, Inc.2013-07-11
REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / recall (Z-1706-2013)Biomet, Inc.2013-07-11
REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / recall (Z-1707-2013)Biomet, Inc.2013-07-11
REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE / recall (Z-1708-2013)Biomet, Inc.2013-07-11
REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE / recall (Z-1709-2013)Biomet, Inc.2013-07-11
REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3 ARCOM UHMWPE / recall (Z-1710-2013)Biomet, Inc.2013-07-11
REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 ARCOM UHMWPE / recall (Z-1711-2013)Biomet, Inc.2013-07-11
REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / recall (Z-1712-2013)Biomet, Inc.2013-07-11
REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE / recall (Z-1713-2013)Biomet, Inc.2013-07-11
REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE / recall (Z-1714-2013)Biomet, Inc.2013-07-11
REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE / recall (Z-1715-2013)Biomet, Inc.2013-07-11
REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / recall (Z-1716-2013)Biomet, Inc.2013-07-11
REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5 ARCOM UHMWPE / recall (Z-1717-2013)Biomet, Inc.2013-07-11
REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE / recall (Z-1718-2013)Biomet, Inc.2013-07-11
REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE / recall (Z-1719-2013)Biomet, Inc.2013-07-11
REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / recall (Z-1720-2013)Biomet, Inc.2013-07-11
REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4 ARCOM UHMWPE / recall (Z-1721-2013)Biomet, Inc.2013-07-11
REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / recall (Z-1722-2013)Biomet, Inc.2013-07-11
REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE / recall (Z-1723-2013)Biomet, Inc.2013-07-11
REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / recall (Z-1724-2013)Biomet, Inc.2013-07-11

PMA approvals by this applicant

RecordFirmDate
Oxford™ Knee System (P010014/S111)Biomet Manufacturing Corp2025-08-07
Oxford Partial Knee System (P010014/S109)Biomet Manufacturing Corp2025-08-07
OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S110)Biomet Manufacturing Corp2025-06-24
Oxford® Partial Knee System (P010014/S107)Biomet Manufacturing Corp2024-11-22
Oxford™ Cementless Partial Knee System (P010014/S105)Biomet Manufacturing Corp2024-11-22
Oxford Partial Knee System (P010014/S108)Biomet Manufacturing Corp2024-11-18
Oxford® Partial Knee System (P010014/S106)Biomet Manufacturing Corp2024-08-19
Oxford Partial Knee (P010014/S104)Biomet Manufacturing Corp2023-04-06