Cleared Traditional

K220650 - TriMed Ripcord Device

K220650 is the FDA 510(k) clearance for TriMed Ripcord Device by TriMed, Inc.. It is a Class 2 Orthopedic device (product code HTN) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K220650 · TriMed, Inc. · Orthopedic device
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Jun 2022
Decision
86d
Days
Class 2
Risk

K220650 is an FDA 510(k) clearance for the TriMed Ripcord Device. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by TriMed, Inc. (Santa Clarita, US). The FDA issued a Cleared decision on June 1, 2022 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all TriMed, Inc. devices

Submission Details

510(k) Number K220650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2022
Decision Date June 01, 2022
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HTN Washer, Bolt Nut
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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

Tech2med, LLC
David Anderson

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 - HTN Washer, Bolt Nut

All 65
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