Cleared Traditional

K161127 - The Small PLATEAU (PLATEAU-C) Spacer System

K161127 is an FDA 510(k) clearance for The Small PLATEAU (PLATEAU-C) Spacer System, manufactured by Life Spine, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K161127 · Life Spine, Inc. · Orthopedic device
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Dec 2016
Decision
245d
Days
Class 2
Risk

K161127 is an FDA 510(k) clearance for the The Small PLATEAU (PLATEAU-C) Spacer System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on December 22, 2016 after a review of 245 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 Life Spine, Inc. devices

FDA 510(k) Submission Details - K161127

510(k) Number K161127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2016
Decision Date December 22, 2016
Days to Decision 245 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
123d slower than avg
Panel avg: 122d · This submission: 245d
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 Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 336
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K161127.
ROCCIA® ACIF
K162587 · Silony Medical GmbH · Jan 2017
nvc
K170074 · Nvision Biomedical Technologies, LLC · Jan 2017
Ayers Rock Cervical interbody fusion system
K162694 · Spineway · Jan 2017
IMSE Cervical Cage
K162003 · The Institute of Musculoskeletal Science & Education · Dec 2016
OIC Cervical PEEK Spacer
K160222 · The Orthopaedic Implant Company · Dec 2016
ShurFit CpTi-HA ACIF Interbody Fusion System
K161809 · Precision Spine, Inc. · Dec 2016