Cleared Traditional

Pre-Sutured Tendon (4561SC / Single Strand) (K230036) - FDA 510(k) Clearance

Also marketed or referenced as:
Pre-Sutured Tendon (4564SC / Quadruple Strand )

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230036 · Rti Surgical, Inc. · General & Plastic Surgery device
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Jun 2023
Decision
178d
Days
Class 2
Risk

K230036 is an FDA 510(k) clearance for the Pre-Sutured Tendon (4561SC / Single Strand). Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Rti Surgical, Inc. (Alachua, US). The FDA issued a Cleared decision on June 23, 2023 after a review of 178 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Rti Surgical, Inc. devices

Submission Details

510(k) Number K230036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2022
Decision Date June 23, 2023
Days to Decision 178 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 115d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 73
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K230036.
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MyEllevate
K230510 · Cynosure, LLC · Jul 2023
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ACTIVBRAID™
K223822 · Embody, Inc. · Jun 2023
Arthrex BioSuture
K220880 · Arthrex, Inc. · Oct 2022
Arthrex SoftStitch
K222078 · Arthrex, Inc. · Sep 2022