510(k) K011643 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

SCORPIO CR SUPERFLEX TIBIAL INSERT

Applicant	Howmedica Osteonics Corp., Allendale NJ, US
Decision	Substantially Equivalent, Jun 28, 2001
Received	May 29, 2001
Type	Special
FDA record	Open on fda.gov

Recalls that name K011643

Date	Firm and product	Code	Linked 510(k)
Jan 31, 2024	Howmedica Osteonics Corp. Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908 Open, Classified	JWH	None listed
Jan 31, 2024	Howmedica Osteonics Corp. Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910 Open, Classified	JWH	None listed

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