Cleared Traditional

K102326 - PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR

K102326 is the FDA 510(k) clearance for PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR by Parcus Medical, LLC. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K102326 · Parcus Medical, LLC · Orthopedic device
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Nov 2010
Decision
90d
Days
Class 2
Risk

K102326 is an FDA 510(k) clearance for the PARCUS 3.5MM PEEK CF PUSH-IN 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 November 15, 2010 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 K102326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2010
Decision Date November 15, 2010
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 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 620
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K102326.
LOW PROFILE SCREWS
K103705 · Arthrex, Inc. · Mar 2011
GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD
K103712 · Depuy Mitek, A Johnson & Johnson Company · Mar 2011
TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND
K102298 · Depuy Mitek, A Johnson & Johnson Company · Jan 2011
PARCUS PEEK CF PUSH-IN SUTURE ANCHOR
K102162 · Parcus Medical, LLC · Nov 2010
IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
K101700 · Extremity Medical, LLC · Oct 2010
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
K101696 · Zimmer, Inc. · Sep 2010