Cleared Traditional

K203855 - CoNextions TR Tendon Repair System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K203855 · Conextions Medical · General & Plastic Surgery device
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Apr 2022
Decision
477d
Days
Class 2
Risk

K203855 is an FDA 510(k) clearance for the CoNextions TR Tendon Repair System. Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Conextions Medical (Salt Lake City, US). The FDA issued a Cleared decision on April 22, 2022 after a review of 477 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4495 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Conextions Medical devices

Submission Details

510(k) Number K203855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2020
Decision Date April 22, 2022
Days to Decision 477 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
363d slower than avg
Panel avg: 114d · This submission: 477d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4495
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice M. Hogan

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.

Clinical Evidence

ClinicalTrials.gov
NCT03622372 Active not recruiting Interventional Industry-sponsored

Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

Pivotal, Randomised, Controlled Trial to Evaluate the Safety and Effectiveness of the CoNextions TR Implant System for Zone 2 Flexor Tendon Repair

90
Patients (actual)
4
Sites
Treatment
Purpose
Double blind
Masking
Condition studied Tendon Injury - Hand
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Michael Solomons, MD
Sponsor CoNextions Medical (industry)
Started 2018-06-21 → Primary completion 2020-06-20 → Completed 2020-12-01
Primary outcome
Rate of tendon re-rupture
Secondary outcome
Visual Analog Score (VAS) for Pain Assessment (0-10 cm scale)
View full study on ClinicalTrials.gov