Cleared Traditional

K150125 - Elite Nitinol Fixation System

K150125 is an FDA 510(k) clearance for Elite Nitinol Fixation System, manufactured by Biomedical Enterprises, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K150125 · Biomedical Enterprises, Inc. · Orthopedic device
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May 2015
Decision
111d
Days
Class 2
Risk

K150125 is an FDA 510(k) clearance for the Elite Nitinol Fixation System. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Biomedical Enterprises, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 11, 2015 after a review of 111 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 Biomedical Enterprises, Inc. devices

FDA 510(k) Submission Details - K150125

510(k) Number K150125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2015
Decision Date May 11, 2015
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 141
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K150125.
OS2-C Compression Staple
K153395 · In2bones Sas · Feb 2016
PediatrOS RigidTack/FlexTack
K151762 · Merete Medical GmbH · Dec 2015
TiTHON Staple with OsseoTi Technology
K151615 · Biomet Manufacturing Corp · Oct 2015
OS2-V Varisation Staple
K143323 · In2bones Sas · Feb 2015
SnapShot Fixation System
K143037 · Biomet Manufacturing Corp · Jan 2015
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
K141263 · Biomet Manufacturing Corp · Nov 2014