Cleared Traditional

K153065 - The Hammertoe Correction System

K153065 is an FDA 510(k) clearance for The Hammertoe Correction System, manufactured by Life Spine, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K153065 · Life Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
284d
Days
Class 2
Risk

K153065 is an FDA 510(k) clearance for the The Hammertoe Correction System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on August 1, 2016 after a review of 284 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 Life Spine, Inc. devices

FDA 510(k) Submission Details - K153065

510(k) Number K153065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2015
Decision Date August 01, 2016
Days to Decision 284 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
162d slower than avg
Panel avg: 122d · This submission: 284d
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 951
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K153065.
AmorChem Titanium Porous Fixation Device
K160791 · Amorchem Holdings, Inc. · Nov 2016
HammerTech Fixation System
K161449 · Fusion Orthopedics, LLC · Oct 2016
I.B.S. 2.0 Osteosynthesis screw
K160174 · In2bones Sas · Oct 2016
Cannulated Screw
K161058 · Miami Device Solutions, LLC · Jul 2016
Arthrosurface Bone Screws
K161539 · Arthrosurface, Inc. · Jun 2016
The Life Spine Subtalar Implant System
K160169 · Life Spine · Jun 2016