Cleared Traditional

K160169 - The Life Spine Subtalar Implant System

K160169 is an FDA 510(k) clearance for The Life Spine Subtalar Implant System, manufactured by Life Spine. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K160169 · Life Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
148d
Days
Class 2
Risk

K160169 is an FDA 510(k) clearance for the The Life Spine Subtalar Implant System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Life Spine (Huntley, US). The FDA issued a Cleared decision on June 23, 2016 after a review of 148 days - within the typical 510(k) review window.

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 devices

FDA 510(k) Submission Details - K160169

510(k) Number K160169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date June 23, 2016
Days to Decision 148 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
26d slower than avg
Panel avg: 122d · This submission: 148d
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 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K160169.
The Hammertoe Correction System
K153065 · Life Spine, Inc. · Aug 2016
Cannulated Screw
K161058 · Miami Device Solutions, LLC · Jul 2016
Arthrosurface Bone Screws
K161539 · Arthrosurface, Inc. · Jun 2016
dynaMX(TM) Nitinol Compression Screw
K160427 · Mx Orthopedics, Corp. · Jun 2016
Large Screws Range
K160617 · Newclip Technics · Jun 2016
OsteoBullet Compression Screw
K160304 · Phalanx Innovations · Apr 2016