Cleared Traditional

K954838 - EZ FIX

K954838 is an FDA 510(k) clearance for EZ FIX, manufactured by Biodynamic Technologies, Inc.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K954838 · Biodynamic Technologies, Inc. · Orthopedic device
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Jan 1996
Decision
96d
Days
Class 2
Risk

K954838 is an FDA 510(k) clearance for the EZ FIX. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Biodynamic Technologies, Inc. (Deerfield Beach, US). The FDA issued a Cleared decision on January 24, 1996 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Biodynamic Technologies, Inc. devices

FDA 510(k) Submission Details - K954838

510(k) Number K954838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1995
Decision Date January 24, 1996
Days to Decision 96 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
26d faster than avg
Panel avg: 122d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEC Device Classification - Class 2, Special Controls

Product Code JEC Component, Traction, Invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JEC Component, Traction, Invasive

All 46
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K954838.
HOFFMANN II CARBON CONNECTING ROD
K961916 · Howmedica, Inc. · Aug 1996
MONOTUBE TUBE TO RING CLAMP
K961618 · Howmedica Corp. · May 1996
TITANIUM TUBE TO TUBE CLAMP
K960782 · Synthes (Usa) · May 1996
MONOTUBE TUBE-TO-TUBE CLAMP
K954667 · Howmedica Corp. · Jan 1996
EXTERNAL FIXATOR
K952330 · Acu Med, Inc. · Oct 1995
HOFFMANN II EXTERNAL FIXATION SYSTEM
K952730 · Howmedica Corp. · Sep 1995