Cleared Traditional

K122113 - MEMORY METAL STAPLES

K122113 is the FDA 510(k) clearance for MEMORY METAL STAPLES by Stryker Corp.. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 K122113.
TiTHON Staple with OsseoTi Technology
K151615 · Biomet Manufacturing Corp · Oct 2015
SnapShot Fixation System
K143037 · Biomet Manufacturing Corp · Jan 2015
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
K141263 · Biomet Manufacturing Corp · Nov 2014
COMPOSITE HITCH SUTURE ANCHOR
K081172 · Biomet Manufacturing Corp · Jul 2008
CAIS STAPLE
K073281 · Depuy Mitek, A Johnson & Johnson Company · May 2008
ARTHREX COMPRESSION STAPLE
K080111 · Arthrex, Inc. · Feb 2008