Cleared Traditional

K161259 - KLS Martin Cannulated Headless Screws

K161259 is the FDA 510(k) clearance for KLS Martin Cannulated Headless Screws by KLS-Martin L.P.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K161259 · KLS-Martin L.P. · Orthopedic device
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Dec 2016
Decision
229d
Days
Class 2
Risk

K161259 is an FDA 510(k) clearance for the KLS Martin Cannulated Headless Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on December 19, 2016 after a review of 229 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 KLS-Martin L.P. devices

Submission Details

510(k) Number K161259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2016
Decision Date December 19, 2016
Days to Decision 229 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
107d slower than avg
Panel avg: 122d · This submission: 229d
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 574
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K161259.
Foot and Hand Motion
K170012 · Newclip Technics · Apr 2017
MICATM Screw System
K162353 · Wrightmedicaltechnologyinc · Apr 2017
DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw
K161616 · Synthes USA Products, LLC · Feb 2017
Tyber Medical BioTy® Nanotopography Trauma Screw
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The Hammertoe Correction System
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The Life Spine Subtalar Implant System
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