Cleared Traditional

K230891 - SURESTITCH UHMWPE Suture PEEK Button Me...

K230891 is an FDA 510(k) clearance for SURESTITCH UHMWPE Suture PEEK Button Me..., manufactured by Healthium Medtech Limited. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K230891 · Healthium Medtech Limited · Orthopedic device
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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. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Healthium Medtech Limited (Bangalore, IN). The FDA issued a Cleared decision on December 28, 2023 after a review of 272 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Healthium Medtech Limited devices

FDA 510(k) Submission Details - K230891

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 122d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 Orthopedic devices follow this clearance model.

Regulatory Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 438
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K230891.
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K233659 · Osteonic Co., Ltd. · Dec 2023
OTS 25 (100-1)
K233429 · Ots Medical , Ltd. · Dec 2023
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K233552 · Riverpoint Medical · Nov 2023