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510(k) K994128 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM

Applicant	Howmedica Osteonics Corp., Allendale NJ, US
Decision	Substantially Equivalent, Mar 6, 2000
Received	Dec 7, 1999
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K994128

Date	Firm and product	Code	Linked 510(k)
Jan 31, 2024	Howmedica Osteonics Corp. SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321 Open, Classified	JWH	None listed
Jan 31, 2024	Howmedica Osteonics Corp. SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510 Open, Classified	JWH	None listed
Jan 31, 2024	Howmedica Osteonics Corp. SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512 Open, Classified	JWH	None listed
Jan 31, 2024	Howmedica Osteonics Corp. SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514 Open, Classified	JWH	None listed
Jan 31, 2024	Howmedica Osteonics Corp. SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516 Open, Classified	JWH	None listed
Jan 31, 2024	Howmedica Osteonics Corp. SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518 Open, Classified	JWH	None listed
Jan 31, 2024	Howmedica Osteonics Corp. SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521 Open, Classified	JWH	None listed
Jan 31, 2024	Howmedica Osteonics Corp. SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524 Open, Classified	JWH	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.