FDA applicant
Tornier, Inc.
FDA records 116 decisions for Tornier, Inc. (Bloomington, MN) from 1995 to 2026: 115 510(k) clearances and 1 De Novo grant. Most are in product codes KWS (Prosthesis, Shoulder, Semi-Constrained…) and PHX (Shoulder Prosthesis, Reverse Configuration). Since 2016 its 510(k)s took a median of 140 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 380 predicates, 224 of them its own earlier devices. 56 recalls are linked to its devices.
FDA’s records also spell it “Tornier”, “Tornier S.A.S.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tornier, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
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