Cleared Traditional

K163265 - Kepler II

K163265 is an FDA 510(k) clearance for Kepler II, manufactured by Orbbo Surgical, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K163265 · Orbbo Surgical, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
137d
Days
Class 2
Risk

K163265 is an FDA 510(k) clearance for the Kepler II. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Orbbo Surgical, LLC (Los Angeles, US). The FDA issued a Cleared decision on April 7, 2017 after a review of 137 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K163265

510(k) Number K163265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2016
Decision Date April 07, 2017
Days to Decision 137 days
Submission Type Traditional
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
15d slower than avg
Panel avg: 122d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Novus Management Group, LLC
Tamala J Wampler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K163265.
MATISSE Anterior Cervical Interbody Fusion Cage System
K162682 · Ctl Medical Corporation · Jun 2017
Fortilink™-C with TETRAfuse™ 3D Technology
K163673 · Rti Surgical, Inc. · May 2017
Foundation 3D Interbody
K162496 · Corelink, LLC · May 2017
NuVasive CoRoent Small Interbody System
K163491 · Nu Vasive, Incorporated · Mar 2017
4CIS® Marlin ACIF Cage System
K162402 · Solco Biomedical Co., Ltd. · Feb 2017
ROCCIA® ACIF
K162587 · Silony Medical GmbH · Jan 2017