INFINITY TOTAL ANKLE SYSTEM— 510(k) K123954

Clearance details

Applicant

Wrightmedicaltechnologyinc

Product code

Code HSN

Device class

Class 2

Regulation

21 CFR 888.3110

Advisory panel

Orthopedic

Date received

2012-12-21

Decision date

2013-04-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Arlington, TN, US

• K253159 — Prophecy Incompass Surgical Planning System2026-06-16
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• K250641 — APEX 3D Total Ankle Replacement System2025-05-01
• K240475 — Hintermann Series H2 Total Ankle System2024-12-02

• K222835 — Prophecy Preoperative Navigation Alignment System2023-01-27
• K213342 — PRO-DENSE LoVisc Bone Graft Substitute2022-01-05
• K212996 — Sterile PHALINX Hammertoe System2021-11-16
• K202815 — PROPHECY Preoperative Navigation Alignment System2021-03-10
• K201259 — ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System2021-01-08

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-1477-2024 — stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplastyClass II·Ongoing·Wright Medical Technology, Inc.·20240306
• Z-2105-2023 — Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.Class II·Ongoing·Wright Medical Technology, Inc.·20230613

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123954.