Cleared Traditional

K231033 - CEPTRE Knotted UHMWPE Suture PEEK Anchor

K231033 is an FDA 510(k) clearance for CEPTRE Knotted UHMWPE Suture PEEK Anchor, 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 268-day FDA review.

K231033 · Healthium Medtech Limited · Orthopedic device
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Jan 2024
Decision
268d
Days
Class 2
Risk

K231033 is an FDA 510(k) clearance for the CEPTRE® Knotted UHMWPE Suture PEEK Anchor. 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 January 4, 2024 after a review of 268 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 - K231033

510(k) Number K231033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2023
Decision Date January 04, 2024
Days to Decision 268 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 122d · This submission: 268d
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 K231033.
ProCinch, QuadCinch
K240194 · Riverpoint Medical · Feb 2024
AlphaVent Knotless SP PEEK Anchor
K233893 · Stryker Endoscopy · Jan 2024
Footprint Mini PK, 3.5mm Suture Anchor
K233730 · Smith & Nephew · Jan 2024
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant
K230891 · Healthium Medtech Limited · Dec 2023
Suture Wing
K233659 · Osteonic Co., Ltd. · Dec 2023
OTS 25 (100-1)
K233429 · Ots Medical , Ltd. · Dec 2023