510(k) K033272 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

DEPUY SIGMA TIBIAL INSERTS

Applicant	DePuy Orthopaedics, Inc., Warsaw IN, US
Decision	Substantially Equivalent, Feb 5, 2004
Received	Oct 10, 2003
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K033272

Date	Firm and product	Code	Linked 510(k)
Nov 27, 2013	DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray Terminated	JWH	None listed
Nov 27, 2013	DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray Terminated	JWH	None listed
Nov 27, 2013	DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray us Terminated	JWH	None listed
Nov 27, 2013	DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tr Terminated	JWH	None listed
Nov 27, 2013	DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tra Terminated	JWH	None listed
Nov 27, 2013	DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray Terminated	JWH	None listed
Nov 27, 2013	DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used Terminated	JWH	None listed
Nov 27, 2013	DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used du Terminated	JWH	None listed
Nov 27, 2013	DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used du Terminated	JWH	None listed
Nov 27, 2013	DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray us Terminated	LXH	None listed
Nov 27, 2013	DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used Terminated	LXH	None listed
Nov 27, 2013	DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2, 8 mm; Ref 1581-11-008. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert , Sz 2.5, 8 mm; Ref 1581-12-008. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2.5, 10 mm; Ref 1581-12-010. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2.5, 17.5 mm; Ref 1581-12-017. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 8 mm; Ref 1581-13-008. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 10 mm; Ref 1581-13-010. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 15 mm; Ref 1581-13-015. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 17.5 mm; Ref 1581-13-017. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 20 mm; Ref 1581-13-020. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 8 mm; Ref 1581-14-008. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4,10 mm; Ref 1581-14-010. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 15 mm; Ref 1581-14-015. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 17.5 mm; Ref 1581-14-017. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 8 mm; Ref 1581-15-008. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 10 mm; Ref 1581-15-010. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 12.5 mm; Ref 1581-15-012. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 15 mm; Ref 1581-15-015. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 17.5 mm; Ref 1581-15-017. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 6, 12.5 mm; Ref 1581-16-012. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 1.5, 8 mm; Ref 1581-20-008. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 1.5, 15 mm; Ref 1581-20-015. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2, 15 mm; Ref 1581-21-015. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2, 20 mm; Ref 1581-21-020. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 1581-22-008. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 10 mm; Ref 1581-22-010. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 12.5 mm; Ref 1581-22-012. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 10 mm; Ref 1581-23-010. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 1581-23-012. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 15 mm; Ref 1581-23-015. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 17.5 mm; Ref 1581-23-017. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 8 mm; Ref 1581-24-008. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 1581-24-010. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 12.5 mm; Ref 1581-24-012. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 15 mm; Ref 1581-24-015. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 17.5 mm; Ref 1581-24-017. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 22.5 mm; Ref 1581-24-022. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 5, 10 mm; Ref 1581-25-010. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 5, 12.5 mm; Ref 1581-25-012. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 5, 22.5 mm; Ref 1581-25-022. Terminated	JWH	None listed

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