Cleared Traditional

K173286 - Cannulated Screw Internal Fixation System

K173286 is an FDA 510(k) clearance for Cannulated Screw Internal Fixation 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 59-day FDA review.

K173286 · Life Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
59d
Days
Class 2
Risk

K173286 is an FDA 510(k) clearance for the Cannulated Screw Internal Fixation 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 December 14, 2017 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Life Spine, Inc. devices

FDA 510(k) Submission Details - K173286

510(k) Number K173286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2017
Decision Date December 14, 2017
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
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 939
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K173286.
G-Beam Fusion Beaming System
K172698 · Orthofix Srl · Feb 2018
HBS2 Headless Bone Screw
K171628 · Stuckenbrock Medizintechnik GmbH · Jan 2018
Arthrosurface Bone Screws
K172383 · Arthrosurface, Inc. · Dec 2017
PIT’Stop® implant
K170688 · In2bones Sas · Nov 2017
VariAx 2 System
K173135 · Stryker GmbH · Nov 2017
Treace Medical Concepts (TMC) Compression Screw System
K172617 · Treace Medical Concepts, Inc. · Oct 2017