Cleared Traditional

K954053 - BERLIN EXTERNAL FIXATOR

K954053 is an FDA 510(k) clearance for BERLIN EXTERNAL FIXATOR, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code LXT cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K954053 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
261d
Days
Class 2
Risk

K954053 is an FDA 510(k) clearance for the BERLIN EXTERNAL FIXATOR. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (product code LXT), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on May 16, 1996 after a review of 261 days - an extended review 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: 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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K954053

510(k) Number K954053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1995
Decision Date May 16, 1996
Days to Decision 261 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
139d slower than avg
Panel avg: 122d · This submission: 261d
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 34
Devices cleared under the same product code (LXT) and FDA review panel - the closest regulatory comparables to K954053.
SYNTHES LOCKING CALCANEAL PLATES
K991407 · Synthes (Usa) · Jun 1999
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
TITANIUM UNIVERSAL CLAMP
K960269 · Synthes (Usa) · Apr 1996
HEX-FIX FIELD FIXATOR
K953397 · Smith & Nephew Richards, Inc. · Oct 1995
SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR
K950384 · Synthes (Usa) · May 1995