Cleared Special

K172587 - Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers

K172587 is an FDA 510(k) clearance for Mecta-C with titanium markers and Mecta..., manufactured by Medacta International S.A.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Special 510(k) pathway after a 21-day FDA review.

K172587 · Medacta International S.A. · Orthopedic device
Download Printable Device Report (PDF)
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Sep 2017
Decision
21d
Days
Class 2
Risk

K172587 is an FDA 510(k) clearance for the Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on September 18, 2017 after a review of 21 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.

View all Medacta International S.A. devices

FDA 510(k) Submission Details - K172587

510(k) Number K172587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2017
Decision Date September 18, 2017
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 Consultant

Mapi USA, Inc.
Elizabeth Rose, MST, RAC (US)

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 336
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