Cleared Traditional

K111000 - PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR

K111000 is an FDA 510(k) clearance for PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITAN..., manufactured by Parcus Medical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K111000 · Parcus Medical, LLC · Orthopedic device
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Jul 2011
Decision
108d
Days
Class 2
Risk

K111000 is an FDA 510(k) clearance for the PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Parcus Medical, LLC (Sturgeon Bay, US). The FDA issued a Cleared decision on July 28, 2011 after a review of 108 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

FDA 510(k) Submission Details - K111000

510(k) Number K111000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2011
Decision Date July 28, 2011
Days to Decision 108 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 122d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 986
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K111000.
NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
K111799 · Ascension Orthopedic · Aug 2011
METASURG SUBTALAR IMPLANT
K111265 · Metasurg · Aug 2011
N-FORCE FIXATION SYSTEM
K102528 · Innovision, Inc. · Jul 2011
3.7MM/5.0MM DYNAMIC LOCKING SCREW
K110592 · Synthes (Usa) · Jul 2011
METASURG DIGIFUSE IMPLANT
K111536 · Metasurg · Jul 2011
AAP CANNULATED SCREWS
K111316 · Aap Implantate AG · Jul 2011