DePuy Corail AMT Hip Prosthesis— 510(k) K192946

Name: FDA 510(k) clearance K192946
Creator: U.S. Food and Drug Administration
Published: 2019-11-26

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K192946 for DePuy Corail AMT Hip Prosthesis, Substantially Equivalent on 2019-11-26. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2019-10-18
Decision date: 2019-11-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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K252401 — implaFit® short stems2026-03-12

More clearances from DePuy Orthopaedics, Inc.

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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
K203167 — DePuy Corail AMT Hip Prosthesis2020-11-19

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.