Cleared Traditional

K162685 - 2-Piece Hammertoe Correction System

K162685 is the FDA 510(k) clearance for 2-Piece Hammertoe Correction System by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K162685 · Life Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
256d
Days
Class 2
Risk

K162685 is an FDA 510(k) clearance for the 2-Piece 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 June 9, 2017 after a review of 256 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

Submission Details

510(k) Number K162685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2016
Decision Date June 09, 2017
Days to Decision 256 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
134d slower than avg
Panel avg: 122d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 567
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K162685.
Large Screws Range
K172596 · Newclip Technics · Oct 2017
Medline UNITE® Snap-Off Screws
K170782 · Medline Industries, Inc. · Aug 2017
Hammertoe Correction System
K171448 · Life Spine, Inc. · Jul 2017
Arthrex Compression Screws
K170382 · Arthrex, Inc. · May 2017
CAPTIVATE™ Compression Screws
K162825 · Globus Medical, Inc. · May 2017
HV Screw System
K170889 · Wrightmedicaltechnologyinc · Apr 2017