Cleared Traditional

K984357 - TRANSFX EXTERNAL FIXATION SYSTEM

K984357 is an FDA 510(k) clearance for TRANSFX EXTERNAL FIXATION SYSTEM, manufactured by Immedica, Inc.. The device is a Class 2 Orthopedic device with product code LXT cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K984357 · Immedica, Inc. · Orthopedic device
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Mar 1999
Decision
87d
Days
Class 2
Risk

K984357 is an FDA 510(k) clearance for the TRANSFX EXTERNAL FIXATION SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (product code LXT), Class II - Special Controls.

Submitted by Immedica, Inc. (Chatham, US). The FDA issued a Cleared decision on March 4, 1999 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Immedica, Inc. devices

FDA 510(k) Submission Details - K984357

510(k) Number K984357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1998
Decision Date March 04, 1999
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LXT Device Classification - Class 2, Special Controls

Product Code LXT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
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 - LXT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite

All 39
Devices cleared under the same product code (LXT) and FDA review panel - the closest regulatory comparables to K984357.
TRANSFX MULTI PIN CLAMP
K991723 · Immedica, Inc. · Jul 1999
SYNTHES LOCKING CALCANEAL PLATES
K991407 · Synthes (Usa) · Jun 1999
TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION
K990848 · Immedica, Inc. · May 1999
DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI
K974245 · Depuy Ace Medical Co. · May 1998
SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
K963618 · Synthes (Usa) · Nov 1996
EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM
K962846 · Biodynamic Technologies, Inc. · Oct 1996