Salto XT, Salto Talaris— 510(k) K153452

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

2015-11-30

Decision date

2016-08-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Montbonnot-Saint-Martin, FR

• K253159 — Prophecy Incompass Surgical Planning System2026-06-16
• K252454 — Kinos Total Ankle System2025-09-03
• 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-1168-2019 — Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1169-2019 — Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1170-2019 — Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1171-2019 — Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1172-2019 — Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1173-2019 — Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1174-2019 — Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192TClass II·Terminated·Integra LifeSciences Corp.·20190308
• Z-1175-2019 — Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193TClass II·Terminated·Integra LifeSciences Corp.·20190308

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153452.