FDA applicant
Encore Orthopedics, Inc.
FDA records 85 decisions for Encore Orthopedics, Inc. (Austin, TX) from 1993 to 2004: 85 510(k) clearances. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and JDI (Prosthesis, Hip, Semi-Constrained…). Its devices cite 36 predicates, 19 of them its own earlier devices. 39 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Encore Orthopedics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Encore Orthopedics, Inc. since 2007.
Recalls per year
1in 2016
Class I Class II/III not classified
Planning a device like Encore 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 “Encore”
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