FDA applicant
Centerpulse Orthopedics, Inc.
FDA records 10 decisions for Centerpulse Orthopedics, Inc. (Austin, TX) from 2003 to 2004: 10 510(k) clearances. Most are in product codes LZO (Prosthesis, Hip, Semi-Constrained…) and KWA (Prosthesis, Hip, Semi-Constrained (Metal…). Its devices cite 27 predicates, 1 of them its own earlier devices. 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Centerpulse Orthopedics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Centerpulse Orthopedics, Inc. since 2007.
Recalls per year
2in 2014
Class I Class II/III not classified
Planning a device like Centerpulse Orthopedics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Centerpulse”
FDA records each applicant name separately; these may or may not be the same firm.