Cleared Traditional

PMT Facet Fixation System (PMT FFS) (K220951) - FDA 510(k) Clearance

K220951 · Providence Medical Technology, Inc. · Orthopedic device
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Dec 2022
Decision
252d
Days
-
Risk

K220951 is an FDA 510(k) clearance for the PMT Facet Fixation System (PMT FFS). 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 December 9, 2022 after a review of 252 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 K220951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2022
Decision Date December 09, 2022
Days to Decision 252 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
130d slower than avg
Panel avg: 122d · This submission: 252d
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 K220951.
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 Expandable Cage (PMT EXP)
K230297 · Providence Medical Technology, Inc. · Aug 2023
FaSet Fixation System
K222515 · Dio Medical Corporation · Oct 2022
Ion Facet Screw System
K211855 · SurGenTec, LLC · Feb 2022
CORRIDOR Fixation System
K192744 · Globus Medical, Inc. · Dec 2019