Cleared Traditional

K012081 - DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM

K012081 is an FDA 510(k) clearance for DYNAMIC COMPRESSION SHAPE MEMORY ALLOY ..., manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K012081 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Oct 2001
Decision
90d
Days
Class 2
Risk

K012081 is an FDA 510(k) clearance for the DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on October 1, 2001 after a review of 90 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 Medtronic Sofamor Danek, Inc. devices

FDA 510(k) Submission Details - K012081

510(k) Number K012081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2001
Decision Date October 01, 2001
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 190
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K012081.
ORTHOPEDIC WIRE
K031127 · Howmedica Osteonics Corp. · Apr 2003
SURETAC III, MODELS 7209900, 7209901
K023417 · Smith & Nephew, Inc. · Nov 2002
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
K020948 · Smith & Nephew, Inc. · Oct 2002
THE UNI-CLIP STAPLE
K011716 · New Deal, S.A. · Aug 2001
SCAPHIX, STAPLE, FIXATION, BONE
K003033 · Avanta Orthopaedics, Inc. · May 2001
MEMOGRAPH STAPLE, WARM SYSTEM
K993714 · Biomedical Ent., Inc. · Feb 2000