Cleared Traditional

K090923 - PARCUS GRAFT FIXATION SYSTEM

K090923 is the FDA 510(k) clearance for PARCUS GRAFT FIXATION SYSTEM by Parcus Medical, LLC. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K090923 · Parcus Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
90d
Days
Class 2
Risk

K090923 is an FDA 510(k) clearance for the PARCUS GRAFT FIXATION SYSTEM. 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 (Sturgeon Bay, US). The FDA issued a Cleared decision on June 30, 2009 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Parcus Medical, LLC devices

Submission Details

510(k) Number K090923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2009
Decision Date June 30, 2009
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 435
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K090923.
SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR
K093228 · Smith & Nephew, Inc. · Dec 2009
PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264
K091094 · Parcus Medical, LLC · Sep 2009
TORNIER, PITON FIXATION IMPLANT SYSTEM
K091870 · Tornier · Sep 2009
CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM
K091549 · Linvatec Corp. · Jun 2009
MAGNUM MP FIXATION DEVICE
K091503 · Arthrocare Corp. · Jun 2009
OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE
K090615 · Arthrocare Corp. · Jun 2009