Icona Hip Stem— 510(k) K261576
Substantially EquivalentCorin, Ltd.
FDA 510(k) clearance K261576 for Icona Hip Stem, Substantially Equivalent on 2026-08-10. Applicant: Corin, Ltd.. Device class: 2.
Summary
Corin's Icona Hip Stem is filed under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate). The record gives no sizes or model numbers.
Class II, 21 CFR 888.3353. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Corin filed from Cirencester, United Kingdom. The decision came 90 calendar days after FDA received it (May 12 to August 10, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Corin, Ltd.
- Product code
- Product code MEH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cirencester, GB
Recent devices under product code MEH
view allMore clearances from Corin, Ltd.
view all- K261275 — Unity Total Knee System, Unity Knee Cementless CR Femur
- K201657 — Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and TS Hip Systems, TaperFit Hip System, Revival Modular Hip System, MiniHip, Trinity Dual Mobility, MobiliT, BiPolar-i, OMNI MOD Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads
- K200888 — OMNIBotics Knee System
Adverse events under product code MEH
product code MEH- Injury
- 2,021
- Total
- 2,021
Source: openFDA MAUDE database, through . 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.