Cleared Special

K120143 - ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL

K120143 is an FDA 510(k) clearance for ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL, manufactured by Apollo Spine. The device is a Class 2 Orthopedic device with product code ODP cleared through the Special 510(k) pathway after a 29-day FDA review.

K120143 · Apollo Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
29d
Days
Class 2
Risk

K120143 is an FDA 510(k) clearance for the ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Apollo Spine (Newbury, US). The FDA issued a Cleared decision on February 16, 2012 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K120143

510(k) Number K120143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2012
Decision Date February 16, 2012
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 352
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K120143.
DEPUY PULSE CERVICAL CAGE SYSTEM
K120517 · Medos International SARL · Apr 2012
SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE
K111820 · Bm Korea Co., Ltd. · Mar 2012
ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K113518 · Spinefrontier, Inc. · Feb 2012
LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS
K113559 · Ldr Spine USA, Inc. · Dec 2011
ZAVATION IBF SYSTEMS
K112664 · Zavation, LLC · Dec 2011
MECTA-C
K112862 · Medacta International · Dec 2011
K120143 · ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
Download PDF FDA Summary Apollo Spine