Cleared Traditional

K183501 - Parcus Twist AP Suture Anchors

K183501 is the FDA 510(k) clearance for Parcus Twist AP Suture Anchors by Parcus Medical, LLC. It is a Class 2 Orthopedic device (product code MAI) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K183501 · Parcus Medical, LLC · Orthopedic device
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Mar 2019
Decision
88d
Days
Class 2
Risk

K183501 is an FDA 510(k) clearance for the Parcus Twist AP Suture Anchors. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Parcus Medical, LLC (Sarasota, US). The FDA issued a Cleared decision on March 15, 2019 after a review of 88 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 Parcus Medical, LLC devices

Submission Details

510(k) Number K183501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2018
Decision Date March 15, 2019
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
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 Peers - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 158
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K183501.
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K180768 · Arthrex, Inc. · Dec 2018