Cleared Traditional

ANYPLUS PEEK CAGES (K100516) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100516 · GS Medical Co., Ltd. · Orthopedic device
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Dec 2010
Decision
283d
Days
Class 2
Risk

K100516 is an FDA 510(k) clearance for the ANYPLUS PEEK CAGES. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by GS Medical Co., Ltd. (Douglassville, US). The FDA issued a Cleared decision on December 3, 2010 after a review of 283 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 GS Medical Co., Ltd. devices

Submission Details

510(k) Number K100516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2010
Decision Date December 03, 2010
Days to Decision 283 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
161d slower than avg
Panel avg: 122d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K100516.
SOVEREIGN SPINAL SYSTEM
K121982 · Medtronic Sofamor Danek · Jul 2012
INDEPENDENCE SPACER
K120101 · Globus Medical, Inc. · Mar 2012
INTERCONTINENTAL PLATE-SPACER
K103382 · Globus Medical, Inc. · May 2011
INTREPID SPINAL SYSTEM
K091813 · Medtronic Sofamor Danek · Nov 2009
INDEPENDENCE SPACER
K082252 · Globus Medical, Inc. · Nov 2008