Cleared Traditional

EZ FIX (K954838) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954838 · Biodynamic Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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 28
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K954838.
MONOTUBE CARBON TUBE
K963614 · Howmedica Corp. · Nov 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
HOFFMANN II EXTERNAL FIXATION SYSTEM
K952730 · Howmedica Corp. · Sep 1995
PELVIC C-CLAMP
K922796 · Synthes (Usa) · Mar 1994