Cleared Traditional

MectaLIF Transforaminal TiPEEK (K200551) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200551 · Medacta Inernational SA · Orthopedic device
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Feb 2021
Decision
346d
Days
Class 2
Risk

K200551 is an FDA 510(k) clearance for the MectaLIF Transforaminal TiPEEK. 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 Medacta Inernational SA (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on February 12, 2021 after a review of 346 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 Medacta Inernational SA devices

Submission Details

510(k) Number K200551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2020
Decision Date February 12, 2021
Days to Decision 346 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
224d slower than avg
Panel avg: 122d · This submission: 346d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Medacta USA
Chris Lussier

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 464
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K200551.
FORZA Ti Spacer System
K203576 · Orthofix, Inc. · Mar 2021
Born PT-LIF Cage HA
K202380 · Spineworxx AG · Feb 2021
Duo Expandable Interbody Fusion System
K210155 · Spineology, Inc. · Feb 2021
INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers
K203278 · Globus Medical, Inc. · Feb 2021
XYPAN Expandable Lumbar Cage System
K203531 · Aegis Spine, Inc. · Jan 2021
VERTACONNECT TLIF Cage
K203327 · Signus Medizintechnik · Jan 2021