INHANCE INTACT— 510(k) K243248

Name: FDA 510(k) clearance K243248
Creator: U.S. Food and Drug Administration
Published: 2024-12-23

Substantially Equivalent

Depuy Ireland UC

FDA 510(k) clearance K243248 for INHANCE INTACT, Substantially Equivalent on 2024-12-23. Applicant: Depuy Ireland UC. Device class: 2.

Clearance details

Applicant: Depuy Ireland UC
Product code: Code PKC
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2024-10-11
Decision date: 2024-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ringaskiddy, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code PKC

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K254154 — FX V135 EASYTECH® Shoulder System2026-05-01
K252129 — AETOS Shoulder System Stemless Humeral Prosthesis2025-10-03
K241873 — OsseoFit Stemless Shoulder System2024-12-11
K240716 — AETOS Shoulder System Stemless Humeral Prosthesis2024-11-20
K221758 — SMR Stemless Anatomic2023-03-17

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K253624 — INHANCE Reverse Shoulder System2026-03-11
K253551 — VELYS Hip Navigation2026-03-06

Adverse events under product code PKC

product code PKC

Injury: 258
Total: 258

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.