Cleared Traditional

K051408 - INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K051408 · Intelifuse, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
29d
Days
Class 2
Risk

K051408 is an FDA 510(k) clearance for the INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Intelifuse, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on June 29, 2005 after a review of 29 days - a notably fast clearance cycle.

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: 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 Intelifuse, Inc. devices

Submission Details

510(k) Number K051408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2005
Decision Date June 29, 2005
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 230
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K051408.
Linkt Compression Staple System
K250712 · Trax Surgical · May 2025
Medline UNITE® REFLEX® Hybrid Nitinol Implant System
K243888 · Medline Industries, LP · Apr 2025
Arthrex DynaNite Nitinol Staples
K243742 · Arthrex, Inc. · Jan 2025
TMC Compression Implant System
K243658 · Treace Medical Concepts · Dec 2024
TMC Compression Implant System
K242415 · Treace Medical Concepts · Sep 2024
COGNiTiON™ Staple System
K240212 · Ortho Solutions UK , Ltd. · Feb 2024