Cleared Traditional

K221502 - Parcus Synd-EZ SS

K221502 is the FDA 510(k) clearance for Parcus Synd-EZ SS by Parcus Medical, LLC. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K221502 · Parcus Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
64d
Days
Class 2
Risk

K221502 is an FDA 510(k) clearance for the Parcus Synd-EZ SS. 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 Parcus Medical, LLC (Sarasota, US). The FDA issued a Cleared decision on July 26, 2022 after a review of 64 days - a notably fast clearance cycle.

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: 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 K221502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2022
Decision Date July 26, 2022
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
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 Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 412
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K221502.
Arthrex Knotless FiberTak Biceps Suture Anchor
K222161 · Arthrex, Inc. · Aug 2022
Auxilock Titanium Screw-In Suture Anchor
K213104 · Auxein Medical Private Limited · Jul 2022
S-Core Implant System
K220901 · Subchondral Solutions, Inc. · Jul 2022
Mitek TIGHT-N Anchor
K221364 · Medos International SARL · Jul 2022
FairFix AM Adjustable Button FairFix PSP Adjustable Button
K221389 · Medacta International S.A. · Jun 2022
X-Twist PEEK Suture Anchor
K221135 · Parcus Medical, LLC · May 2022