Exactech Vantage Total Ankle System— 510(k) K152217

Clearance details

Applicant

Exactech, Inc.

Product code

Code HSN

Device class

Class 2

Regulation

21 CFR 888.3110

Advisory panel

Orthopedic

Date received

2015-08-07

Decision date

2016-03-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Gainesville, FL, US

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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-0587-2024 — Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03Class II·Ongoing·Exactech, Inc.·20231121
• Z-0024-2022 — Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.Class II·Ongoing·Exactech, Inc.·20210830
• Z-2926-2020 — The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.Class II·Ongoing·Exactech, Inc.·20200810
• Z-2966-2018 — Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.Class II·Terminated·Exactech, Inc.·20180713
• Z-0200-2018 — Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.Class II·Terminated·Exactech, Inc.·20170516
• Z-0201-2018 — Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.Class II·Terminated·Exactech, Inc.·20170516

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152217.