Cleared Traditional

K141798 - SYPHER SPACER SYSTEM

K141798 is an FDA 510(k) clearance for SYPHER SPACER SYSTEM, manufactured by Biogennix, LLC. The device is a Class 2 Orthopedic device with product code OVD cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K141798 · Biogennix, LLC · Orthopedic device
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Feb 2015
Decision
231d
Days
Class 2
Risk

K141798 is an FDA 510(k) clearance for the SYPHER SPACER SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Biogennix, LLC (Colorado Springs, US). The FDA issued a Cleared decision on February 19, 2015 after a review of 231 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Biogennix, LLC devices

FDA 510(k) Submission Details - K141798

510(k) Number K141798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2014
Decision Date February 19, 2015
Days to Decision 231 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
109d slower than avg
Panel avg: 122d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVD Device Classification - Class 2, Special Controls

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 161
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K141798.
ALIF Interfixated System
K151214 · Nu Vasive, Incorporated · Jun 2015
Chesapeake Stabilization System
K142487 · K2m, Inc. · May 2015
MAGNIFY and MAGNIFY-S Spacers
K142498 · Globus Medical, Inc. · Feb 2015
AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System
K143163 · Stryker Corporation · Jan 2015
IMPIX ALIF S/A
K141187 · Medicrea International SA · Jan 2015
AERO-LL LUMBAR CAGE SYSTEM
K142066 · Stryker Corporation · Nov 2014