Cleared Traditional

K230891 - SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant (FDA 510(k) Clearance)

K230891 · Healthium Medtech Limited · Orthopedic device

Dec 2023

Decision

272d

Days

Class 2

Risk

K230891 is an FDA 510(k) clearance for the SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).

Submitted by Healthium Medtech Limited (Bangalore, IN). The FDA issued a Cleared decision on December 28, 2023, 272 days after receiving the submission on March 31, 2023.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K230891 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 31, 2023
Decision Date	December 28, 2023
Days to Decision	272 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF