Cleared Traditional

K150693 - PHIN-FX Cannulated Lag Screw System

K150693 is an FDA 510(k) clearance for PHIN-FX Cannulated Lag Screw System, manufactured by Ascent Medical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K150693 · Ascent Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Oct 2015
Decision
209d
Days
Class 2
Risk

K150693 is an FDA 510(k) clearance for the PHIN-FX Cannulated Lag Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Ascent Medical, LLC (Jackson, US). The FDA issued a Cleared decision on October 13, 2015 after a review of 209 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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. 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 Ascent Medical, LLC devices

FDA 510(k) Submission Details - K150693

510(k) Number K150693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2015
Decision Date October 13, 2015
Days to Decision 209 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 122d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 Peers - HWC Screw, Fixation, Bone

All 739
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K150693.
Tyber Medical MST Trauma Screw
K153180 · Tyber Medical, LLC · Nov 2015
Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
K152841 · Zimmer, Inc. · Nov 2015
HammerFiX Device
K152710 · Extremity Medical, LLC · Oct 2015
PRO-TOE Hammertoe Fixation System
K151838 · Wrightmedicaltechnologyinc · Sep 2015
ForeFoot STP System
K150871 · Tornier, Inc. · Aug 2015
OsteoMed Cannulated Screw System
K151021 · Osteomed Corp. · Jul 2015