Cleared Traditional

Memo 3D Semirigid Annuloplasty Ring (K230318) - FDA 510(k) Clearance

Also marketed or referenced as:
Memo 3D ReChord Semirigid Annuloplasty Ring Memo 4D Semirigid Annuloplasty Ring

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230318 · Corcym S.r.l. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
60d
Days
Class 2
Risk

K230318 is an FDA 510(k) clearance for the Memo 3D Semirigid Annuloplasty Ring. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Corcym S.r.l. (Saluggia, IT). The FDA issued a Cleared decision on April 7, 2023 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Corcym S.r.l. devices

Submission Details

510(k) Number K230318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2023
Decision Date April 07, 2023
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRH Ring, Annuloplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - KRH Ring, Annuloplasty

All 33
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K230318.
TransForm McCarthy Mitral Annuloplasty Ring (TF)
K250859 · Genesee Biomedical, Inc. · Jul 2025
TransForm McCarthy Mitral Annuloplasty Ring (TF)
K232599 · Genesee Biomedical, Inc. · Apr 2024
WellsForm Tricuspid Annuloplasty Band (WF)
K230679 · Genesee Biomedical, Inc. · May 2023
TruForm Sievers Annuloplasty Ring
K202253 · Genesee Biomedical, Inc. · Oct 2020
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
K201449 · Medtronic, Inc. · Jul 2020
Physio Flex Annuloplasty Ring
K192762 · Edwards Lifesciences, LLC · Dec 2019