Cleared Traditional

K990848 - TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION

K990848 is an FDA 510(k) clearance for TRANSFX INTERMEDIATE EXTERNAL FIXATION ..., 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 63-day FDA review.

K990848 · Immedica, Inc. · Orthopedic device
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May 1999
Decision
63d
Days
Class 2
Risk

K990848 is an FDA 510(k) clearance for the TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION.... 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 May 17, 1999 after a review of 63 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 - K990848

510(k) Number K990848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1999
Decision Date May 17, 1999
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 K990848.
ULTIMAX HAIG II NAIL SYSTEM
K991889 · Encore Orthopedics, Inc. · Aug 1999
TRANSFX MULTI PIN CLAMP
K991723 · Immedica, Inc. · Jul 1999
SYNTHES LOCKING CALCANEAL PLATES
K991407 · Synthes (Usa) · Jun 1999
TRANSFX EXTERNAL FIXATION SYSTEM
K984357 · Immedica, Inc. · Mar 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