Atlas FDA

MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS

FDA 510(k) clearance K071117 · decided 2007-05-18

Clearance details

K-number
K071117
Device name
MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS
Applicant
DePuy Orthopaedics, Inc.
Decision
Substantially Equivalent
Date received
2007-04-20
Decision date
2007-05-18
Days to decision
28 days
Clearance type
Special
Product code
KWZ
Device class
2
Regulation number
888.3310
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
S-Rom Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch recall (Z-2414-2012)DePuy Orthopaedics, Inc.2012-09-20

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