Cleared Traditional

K200301 - UNiTi ACDF Implant System (FDA 510(k) Clearance)

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

K200301 · Pressio, Inc. · Orthopedic device
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Feb 2021
Decision
363d
Days
Class 2
Risk

K200301 is an FDA 510(k) clearance for the UNiTi ACDF Implant System. Classified as Anterior Staple As Supplemental Fixation For Fusion (product code PHQ), Class II - Special Controls.

Submitted by Pressio, Inc. (San Antonio, US). The FDA issued a Cleared decision on February 3, 2021 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Pressio, Inc. devices

Submission Details

510(k) Number K200301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2020
Decision Date February 03, 2021
Days to Decision 363 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
241d slower than avg
Panel avg: 122d · This submission: 363d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHQ Anterior Staple As Supplemental Fixation For Fusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
Definition Anterior Cervical Device For Supplemental Fixation To Support A Fusion.
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

Empirical Testing Corp
Nathan Wright

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.