Cleared Traditional

K223114 - Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors (FDA 510(k) Clearance)

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

K223114 · Gm Dos Reis Industria E Comerico Ltda. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2023
Decision
303d
Days
Class 2
Risk

K223114 is an FDA 510(k) clearance for the Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors. 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 Gm Dos Reis Industria E Comerico Ltda. (Campinas, BR). The FDA issued a Cleared decision on August 2, 2023 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Gm Dos Reis Industria E Comerico Ltda. devices

Submission Details

510(k) Number K223114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2022
Decision Date August 02, 2023
Days to Decision 303 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
181d slower than avg
Panel avg: 122d · This submission: 303d
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 Consultant

Pr Servicos Regulatorios Administrativos Ltda
Homero Santiago Antunes

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 590
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