Cleared Traditional

K170389 - TAURUS PEEK Cage System

K170389 is an FDA 510(k) clearance for TAURUS PEEK Cage System, manufactured by Medyssey USA, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K170389 · Medyssey USA, Inc. · Orthopedic device
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Dec 2017
Decision
309d
Days
Class 2
Risk

K170389 is an FDA 510(k) clearance for the TAURUS PEEK Cage System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Medyssey USA, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on December 14, 2017 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medyssey USA, Inc. devices

FDA 510(k) Submission Details - K170389

510(k) Number K170389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2017
Decision Date December 14, 2017
Days to Decision 309 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
187d slower than avg
Panel avg: 122d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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

Mrc-X, LLC
Christine Scifert

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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 896
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K170389.
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