Cleared Traditional

K083609 - KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE

K083609 is an FDA 510(k) clearance for KFX PEEK BONE ANCHOR WITH PRE-ATTACHED ..., manufactured by Kfx Medical. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K083609 · Kfx Medical · Orthopedic device
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Mar 2009
Decision
88d
Days
Class 2
Risk

K083609 is an FDA 510(k) clearance for the KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE. 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 Kfx Medical (Carlsbad, 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 Kfx Medical devices

FDA 510(k) Submission Details - K083609

510(k) Number K083609 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
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.

MBI Device Classification - Class 2, Special Controls

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 565
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K083609.
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