CORIN TRIFIT TS HIP— 510(k) K121563

Name: FDA 510(k) clearance K121563
Creator: U.S. Food and Drug Administration
Published: 2012-10-05

Substantially Equivalent

Corin USA

FDA 510(k) clearance K121563 for CORIN TRIFIT TS HIP, Substantially Equivalent on 2012-10-05. Applicant: Corin USA. Device class: 2.

Clearance details

Applicant: Corin USA
Product code: Code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2012-05-29
Decision date: 2012-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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K251166 — Mfinity Femoral System2025-06-13
K251052 — Trivicta® Hip Stem2025-05-22
K242315 — Resolve Modular Revision Hip Stem2025-05-01

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Adverse events under product code MEH

product code MEH

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 →

Recalls naming K121563

K-number listed on FDA's recall record

Z-2603-2021 — Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.Class II·Terminated·Corin Ltd·20210728

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121563.

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