Atlas FDA

MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM

FDA 510(k) clearance K081620 · decided 2008-06-30

Clearance details

K-number
K081620
Device name
MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
Applicant
DePuy Orthopaedics, Inc.
Decision
Substantially Equivalent
Date received
2008-06-09
Decision date
2008-06-30
Days to decision
21 days
Clearance type
Special
Product code
KWS
Device class
2
Regulation number
888.3660
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
Depuy DELTA Xtend, Standard humeral PE Cup Dia 38/+3 STD, sterile, Depuy France; REF 13073 recall (Z-0532-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 1307 recall (Z-0533-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+9 STD, sterile, Depuy France; REF 1307 recall (Z-0534-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+6R RET, sterile, Depuy France; REF 130 recall (Z-0535-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+3 STD, sterile, Depuy France; REF 1307 recall (Z-0536-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+6 STD, sterile, Depuy France; REF 1307 recall (Z-0537-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+9 STD, sterile, Depuy France; REF 1307 recall (Z-0538-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy France; REF 1307 recall (Z-0539-2009)Depuy Orthopaedics, Inc.2009-01-15

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