Cleared Traditional

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

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

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

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
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.

Device Classification

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 321
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K230891.
AlphaVent Knotless SP PEEK Anchor
K233893 · Stryker Endoscopy · Jan 2024
Footprint Mini PK, 3.5mm Suture Anchor
K233730 · Smith & Nephew · Jan 2024
CEPTRE® Knotted UHMWPE Suture PEEK Anchor
K231033 · Healthium Medtech Limited · Jan 2024
Suture Wing
K233659 · Osteonic Co., Ltd. · Dec 2023
OTS 25 (100-1)
K233429 · Ots Medical , Ltd. · Dec 2023
IDEAL Ziploop
K233552 · Riverpoint Medical · Nov 2023