Cleared Traditional

K260995 - DynaNail Helix® Fixation System

K260995 is an FDA 510(k) clearance for DynaNail Helix Fixation System, manufactured by MedShape, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K260995 · MedShape, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
181d
Days
Class 2
Risk

K260995 is an FDA 510(k) clearance for the DynaNail Helix® Fixation System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by MedShape, Inc. (Atlanta, US). The FDA issued a Cleared decision on September 23, 2026 after a review of 181 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 MedShape, Inc. devices

FDA 510(k) Submission Details - K260995

510(k) Number K260995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2026
Decision Date September 23, 2026
Days to Decision 181 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
59d slower than avg
Panel avg: 122d · This submission: 181d
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 1020
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K260995.
OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts
K263116 · OsteoCentric Technologies · Oct 2026
Arthrex Beaming System
K262975 · Arthrex, Inc. · Sep 2026
F.A.S.T Screw
K254280 · Steps Ortho · Sep 2026
ActivaScrew™ Cannulated COM
K261057 · Bioretec, Ltd. · Sep 2026
OsteoCoil™ GT Active Compression System
K260106 · Flower Orthopedics Corporation DBA Conventus Flower Orthoped · Aug 2026
Large Compression Screws
K262344 · TriMed, Inc. · Aug 2026