DEPUY SIGMA TIBIAL INSERTS

FDA 510(k) clearance K033272 · decided 2004-02-05

Clearance details

K-number: K033272
Device name: DEPUY SIGMA TIBIAL INSERTS
Applicant: DePuy Orthopaedics, Inc.
Decision: Substantially Equivalent
Date received: 2003-10-10
Decision date: 2004-02-05
Days to decision: 118 days
Clearance type: Traditional
Product code: JWH
Device class: 2
Regulation number: 888.3560
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

Record	Firm	Date
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee I recall (Z-0412-2014)	DePuy Orthopaedics, Inc.	2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Ins recall (Z-0413-2014)	DePuy Orthopaedics, Inc.	2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Ins recall (Z-0414-2014)	DePuy Orthopaedics, Inc.	2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Kne recall (Z-0415-2014)	DePuy Orthopaedics, Inc.	2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee recall (Z-0416-2014)	DePuy Orthopaedics, Inc.	2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee recall (Z-0417-2014)	DePuy Orthopaedics, Inc.	2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instru recall (Z-0418-2014)	DePuy Orthopaedics, Inc.	2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrume recall (Z-0419-2014)	DePuy Orthopaedics, Inc.	2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrume recall (Z-0420-2014)	DePuy Orthopaedics, Inc.	2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Ins recall (Z-0421-2014)	DePuy Orthopaedics, Inc.	2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instr recall (Z-0422-2014)	DePuy Orthopaedics, Inc.	2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instr recall (Z-0423-2014)	DePuy Orthopaedics, Inc.	2013-11-27
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2, 8 mm; Ref 1581-11-008. recall (Z-1154-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert , Sz 2.5, 8 mm; Ref 1581-12-0 recall (Z-1155-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2.5, 10 mm; Ref 1581-12-0 recall (Z-1156-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2.5, 17.5 mm; Ref 1581-12 recall (Z-1157-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 8 mm; Ref 1581-13-008. recall (Z-1158-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 10 mm; Ref 1581-13-010 recall (Z-1159-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 15 mm; Ref 1581-13-015 recall (Z-1160-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 17.5 mm; Ref 1581-13-0 recall (Z-1161-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 20 mm; Ref 1581-13-020 recall (Z-1162-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 8 mm; Ref 1581-14-008. recall (Z-1163-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4,10 mm; Ref 1581-14-010. recall (Z-1164-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 15 mm; Ref 1581-14-015 recall (Z-1165-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 17.5 mm; Ref 1581-14-0 recall (Z-1166-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 8 mm; Ref 1581-15-008. recall (Z-1167-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 10 mm; Ref 1581-15-010 recall (Z-1168-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 12.5 mm; Ref 1581-15-0 recall (Z-1169-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 15 mm; Ref 1581-15-015 recall (Z-1170-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 17.5 mm; Ref 1581-15-0 recall (Z-1171-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 6, 12.5 mm; Ref 1581-16-0 recall (Z-1172-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 1.5, 8 mm; Ref 1581-2 recall (Z-1173-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 1.5, 15 mm; Ref 1581- recall (Z-1174-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2, 15 mm; Ref 1581-21 recall (Z-1175-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2, 20 mm; Ref 1581-21 recall (Z-1176-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 1581-2 recall (Z-1177-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 10 mm; Ref 1581- recall (Z-1178-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 12.5 mm; Ref 158 recall (Z-1179-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 10 mm; Ref 1581-23 recall (Z-1180-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 1581- recall (Z-1181-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 15 mm; Ref 1581-23 recall (Z-1182-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 17.5 mm; Ref 1581- recall (Z-1183-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 8 mm; Ref 1581-24- recall (Z-1184-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 1581-24 recall (Z-1185-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 12.5 mm; Ref 1581- recall (Z-1186-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 15 mm; Ref 1581-24 recall (Z-1187-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 17.5 mm; Ref 1581- recall (Z-1188-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 22.5 mm; Ref 1581- recall (Z-1189-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 5, 10 mm; Ref 1581-25 recall (Z-1190-05)	Depuy Orthopaedics, Inc.	2005-08-12
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 5, 12.5 mm; Ref 1581- recall (Z-1191-05)	Depuy Orthopaedics, Inc.	2005-08-12

PMA approvals by this applicant

Record	Firm	Date
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