Cleared Traditional

K101765 - KYPHON ANCHOR FACET SCREW SYSTEM

K101765 · Medtronic Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
121d
Days
-
Risk

K101765 is an FDA 510(k) clearance for the KYPHON ANCHOR FACET SCREW SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Medtronic Spine, LLC (Sunnyvale, US). The FDA issued a Cleared decision on October 22, 2010 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel. 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 Medtronic Spine, LLC devices

Submission Details

510(k) Number K101765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2010
Decision Date October 22, 2010
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRW System, Facet Screw Spinal Device
Device Class -

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 49
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K101765.
RAPTOR FACET FIXATION SYSTEM
K110170 · Alphatec Spine, Inc. · Nov 2011
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · Exactech, Inc. · Nov 2011
VIPER F2 FACET FIXATION SYSTEM
K101762 · Depuy Spine, Inc. · Nov 2010
FACET SCREW SYSTEM
K101284 · Nuvasive, Inc. · Jul 2010
FIXCET SPINAL FACET SCREW SYSTEM
K100154 · X-Spine Systems, Inc. · May 2010
SPINEOLOGY FACET SCREW
K092464 · Spineology, Inc. · Nov 2009