Cleared Traditional

K083619 - PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020

K083619 is an FDA 510(k) clearance for PARCUS TINTANIUM INTERFERENCE SCREW, 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 88-day FDA review.

K083619 · Parcus Medical, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2009
Decision
88d
Days
Class 2
Risk

K083619 is an FDA 510(k) clearance for the PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-.... 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 March 6, 2009 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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

FDA 510(k) Submission Details - K083619

510(k) Number K083619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2008
Decision Date March 06, 2009
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.

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
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