Cleared Traditional

K140358 - COMPRESSYN STAPLE

K140358 is an FDA 510(k) clearance for COMPRESSYN STAPLE, manufactured by Dallen Medical, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K140358 · Dallen Medical, Inc. · Orthopedic device
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Jun 2014
Decision
110d
Days
Class 2
Risk

K140358 is an FDA 510(k) clearance for the COMPRESSYN STAPLE. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Dallen Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on June 2, 2014 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Dallen Medical, Inc. devices

FDA 510(k) Submission Details - K140358

510(k) Number K140358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2014
Decision Date June 02, 2014
Days to Decision 110 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 122d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 138
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K140358.
SnapShot Fixation System
K143037 · Biomet Manufacturing Corp · Jan 2015
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
K141263 · Biomet Manufacturing Corp · Nov 2014
ORTHOHELIX STAPLE SYSTEM
K142148 · Orthohelix Surgical Designs, Inc. · Aug 2014
ORTHOHELIX STAPLE SYSTEM
K130832 · Orthohelix Surgical Designs, Inc. · Aug 2013
MEMORY METAL STAPLES, EASYCLIP
K122113 · Stryker Corp. · Mar 2013
COMPOSITE HITCH SUTURE ANCHOR
K081172 · Biomet Manufacturing Corp · Jul 2008