Cleared Traditional

K012081 - DYNAMIC COMPRESSION SHAPE MEMORY ALLOY ...

K012081 is the FDA 510(k) clearance for DYNAMIC COMPRESSION SHAPE MEMORY ALLOY ... by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 99
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
LACTOSORB POP RIVET
K981798 · Biomet, Inc. · Jul 1998
HOWMEDICA MAINSTAY ANCHOR
K965175 · Howmedica Corp. · Mar 1997
ACUFEX TAG BIOABSORBABLE ANCHORS
K961555 · Acufex Microsurgical, Inc. · Jul 1996