Cleared Traditional

K171448 - Hammertoe Correction System

K171448 is an FDA 510(k) clearance for 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 51-day FDA review.

K171448 · Life Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
51d
Days
Class 2
Risk

K171448 is an FDA 510(k) clearance for 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 July 7, 2017 after a review of 51 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 - K171448

510(k) Number K171448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2017
Decision Date July 07, 2017
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
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 K171448.
FuzeFix Screw System
K170038 · Fusion Orthopedics, LLC · Aug 2017
Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System
K162153 · Ascension Orthopedics · Jul 2017
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
K171018 · Extremity Medical, LLC · Jul 2017
Cannulated Screws Neoortho
K162874 · Neoortho Produtos Ortopedicos S/A · Jun 2017
Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw
K170571 · Tyber Medical, LLC · Jun 2017
2-Piece Hammertoe Correction System
K162685 · Life Spine, Inc. · Jun 2017