Cleared Traditional

PMT Expandable Cage (PMT EXP) (K230297) - FDA 510(k) Clearance

K230297 · Providence Medical Technology, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2023
Decision
190d
Days
-
Risk

K230297 is an FDA 510(k) clearance for the PMT Expandable Cage (PMT EXP). Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Providence Medical Technology, Inc. (Pleasanton, US). The FDA issued a Cleared decision on August 11, 2023 after a review of 190 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. 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 Providence Medical Technology, Inc. devices

Submission Details

510(k) Number K230297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2023
Decision Date August 11, 2023
Days to Decision 190 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
68d slower than avg
Panel avg: 122d · This submission: 190d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRW System, Facet Screw Spinal Device
Device Class -

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 31
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K230297.
Ion 3D
K240086 · SurGenTec, LLC · Feb 2024
PMT Facet Fixation System, Lumbar (PMT FFS-LX)
K230840 · Providence Medical Technology, Inc. · Dec 2023
FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System
K232877 · K&J Consulting Corporation · Dec 2023
PMT Facet Fixation System (PMT FFS)
K220951 · Providence Medical Technology, Inc. · Dec 2022
FaSet Fixation System
K222515 · Dio Medical Corporation · Oct 2022
Ion Facet Screw System
K211855 · SurGenTec, LLC · Feb 2022