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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Engineering Consulting Services, Inc.
AL LIPPINCOTT

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 - HWC Screw, Fixation, Bone

All 1056
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K150693.
EzFuze Implant System
K150211 · Vilex IN Tennessee, Inc. · Nov 2015
Integra DigiFuse Cannulated Intramedullary Fusion System
K152527 · Ascension Orthopedics · Oct 2015
HammerFiX Device
K152710 · Extremity Medical, LLC · Oct 2015
CrossRoads Screw System
K152072 · Crossroads Extremity Systems, LLC · Sep 2015
CrossTIE Intraosseous Fixation System
K151270 · Crossroads Extremity Systems, LLC · Sep 2015
PRO-TOE Hammertoe Fixation System
K151838 · Wrightmedicaltechnologyinc · Sep 2015
K150693 · PHIN-FX Cannulated Lag Screw System
Download PDF FDA Summary Ascent Medical, LLC