Cleared Traditional

K122113 - MEMORY METAL STAPLES, EASYCLIP

K122113 is an FDA 510(k) clearance for MEMORY METAL STAPLES, manufactured by Stryker Corp.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K122113 · Stryker Corp. · Orthopedic device
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Mar 2013
Decision
238d
Days
Class 2
Risk

K122113 is an FDA 510(k) clearance for the MEMORY METAL STAPLES, EASYCLIP. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Stryker Corp. (Mahwah, US). The FDA issued a Cleared decision on March 12, 2013 after a review of 238 days - an extended review 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: 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 Stryker Corp. devices

FDA 510(k) Submission Details - K122113

510(k) Number K122113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2012
Decision Date March 12, 2013
Days to Decision 238 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
116d slower than avg
Panel avg: 122d · This submission: 238d
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 191
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K122113.
FUSEFORCE IMPLANT SYSTEM
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K123926 · Metasurg · May 2013
COMPRESSYN STAPLE
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SUPER STAPLE(TM) CLASSIC
K123363 · Metric Medical Devices, Inc. · Jan 2013
VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)
K112837 · Vilex, Inc. · Oct 2012