SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS— 510(k) K130533

Clearance details

Applicant

Tornier S.A.S.

Product code

Code HSN

Device class

Class 2

Regulation

21 CFR 888.3110

Advisory panel

Orthopedic

Date received

2013-03-01

Decision date

2013-05-17

Decision

Substantially Equivalent

Clearance type

Special

Location

Montbonnot-Saint-Martin, FR

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• K250037 — Incompass Total Ankle System2025-06-20
• K250641 — APEX 3D Total Ankle Replacement System2025-05-01
• K240475 — Hintermann Series H2 Total Ankle System2024-12-02

• K232265 — BLUEPRINT Patient Specific Instrumentation2024-02-21
• K222510 — Blueprint Mixed Reality system2023-01-20
• DEN220012 — Tornier Pyrocarbon Humeral Head2022-12-16
• K203315 — BLUEPRINT Patient Specific Instrumentation2021-04-15
• K190521 — Aequalis Ascend Flex Shoulder System2019-06-12

Death

3

Injury

4,711

Total

4,714

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1150-2019 — Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1151-2019 — Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1152-2019 — Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1153-2019 — Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1154-2019 — Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1155-2019 — Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1156-2019 — Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1157-2019 — Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1158-2019 — Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1159-2019 — Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1160-2019 — Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1161-2019 — Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1162-2019 — Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1163-2019 — Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1164-2019 — Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1165-2019 — Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1166-2019 — Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1167-2019 — Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-2465-2015 — Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical InstrumentClass II·Terminated·Tornier, Inc·20150806

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130533.