DePuy Actis Duofox Hip Prosthesis— 510(k) K150862

Clearance details

Applicant

DePuy Orthopaedics, Inc.

Product code

Code MEH

Device class

Class 2

Regulation

21 CFR 888.3353

Advisory panel

Orthopedic

Date received

2015-04-01

Decision date

2015-09-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• K251166 — Mfinity Femoral System2025-06-13
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• K242315 — Resolve Modular Revision Hip Stem2025-05-01

• K262130 — ATTUNE Revision Knee System2026-09-04
• K252887 — DePuy ATTUNE Knee System2026-05-22
• K231503 — CUPTIMIZE Advanced2023-08-22
• K213839 — DePuy Corail AMT Hip Prosthesis2022-01-06
• K210167 — DELTA XTEND Reverse Shoulder System2021-02-19

Injury

2,021

Total

2,021

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-0650-2017 — ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFUClass II·Terminated·Depuy Orthopaedics Inc.·20161025

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150862.