Cleared Traditional

K102121 - ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR

K102121 is an FDA 510(k) clearance for ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR, manufactured by Apollo Spine, Inc.. The device is a Class 2 Orthopedic device with product code OVD cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K102121 · Apollo Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
167d
Days
Class 2
Risk

K102121 is an FDA 510(k) clearance for the ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Apollo Spine, Inc. (Stoughton, US). The FDA issued a Cleared decision on January 12, 2011 after a review of 167 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 Apollo Spine, Inc. devices

FDA 510(k) Submission Details - K102121

510(k) Number K102121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2010
Decision Date January 12, 2011
Days to Decision 167 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
45d slower than avg
Panel avg: 122d · This submission: 167d
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 168
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K102121.
INTERCONTINENTAL PLATE-SPACER
K103382 · Globus Medical, Inc. · May 2011
VAULT ALIF SYSTEM
K103369 · Spinal USA · Apr 2011
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM
K102402 · Alphatec Spine, Inc. · Mar 2011
ANYPLUS PEEK CAGES
K100516 · GS Medical Co., Ltd. · Dec 2010
VU APOD INTERVERTEBRAL BODY FUSION DEVICE
K101310 · Theken Spine, LLC · Sep 2010
AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM
K100802 · Aesculap Implant Systems, Inc. · Jul 2010