Who is the manufacturer of BERLIN EXTERNAL FIXATOR?

Encore Orthopedics, Inc. filed the 510(k) submission for BERLIN EXTERNAL FIXATOR (K954053).

What is the FDA product code for BERLIN EXTERNAL FIXATOR?

LXT. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for BERLIN EXTERNAL FIXATOR?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BERLIN EXTERNAL FIXATOR?

Ilizarov device (Smith-Nephew Richards).

Who can help prepare an FDA 510(k) submission like BERLIN EXTERNAL FIXATOR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BERLIN EXTERNAL FIXATOR

K954053 · Encore Orthopedics, Inc. · LXT · May 16, 1996 · Orthopedic

Device Facts

Record ID	K954053
Device Name	BERLIN EXTERNAL FIXATOR
Applicant	Encore Orthopedics, Inc.
Product Code	LXT · Orthopedic
Decision Date	May 16, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Berlin External Fixator is a wire connected ring or frame fixator. It can be used as a static fixator or dynamically applying distraction or compression. The Berlin Fixator has been designed as a modular construction system. Through the use of a few individual components, simple static fixation procedures can be achieved. The range of indications includes treatment of acute fractures and reconstructive surgery of all long bones.

Device Story

Modular wire-connected ring/frame external fixator; aluminum and stainless steel construction. Used for static fixation or dynamic distraction/compression of long bones. Operated by orthopedic surgeons in clinical/surgical settings. Provides mechanical stabilization for fracture healing and reconstructive procedures. Output is physical skeletal stabilization. Benefit: fracture management and bone reconstruction.

Clinical Evidence

Bench testing only. Static and dynamic compression testing performed on small, medium, and large diameter ring assemblies. Static load to failure: 600 N (Berlin and Ilizarov). Cyclic load testing at 300 N: Berlin assemblies survived 194,000–253,000 cycles vs. 346,000 cycles for Ilizarov.

Technological Characteristics

Modular ring/frame fixator; materials: aluminum and stainless steel. Mechanical fixation via wires. Static or dynamic distraction/compression capability.

Indications for Use

Indicated for patients requiring treatment of acute fractures and reconstructive surgery of all long bones.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

Ilizarov device (Smith-Nephew Richards)

Related Devices

K083789 — ACE FISCHER EXTERNAL FIXATION SYSTEM · DePuy Orthopaedics, Inc. · Mar 23, 2009
K050048 — HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM · Howmedica Osteonics Corp. · Mar 4, 2005
K052037 — MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM · Howmedica Osteonics Corp. · Aug 5, 2005
K140961 — HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM · Stryker Trauma AG · Nov 10, 2014
K182968 — Hoffmann LRF System · Stryker GmbH · Jan 25, 2019

Submission Summary (Full Text)

{0} August 25, 1995 K954053 MAY 16 1996 # Summary of Safety and Effectiveness Encore Orthopedics®, Inc. 8920 Business Park Drive Suite 380 Austin, TX 78759 512-795-8696 J.D. Webb ## Trade Name: Berlin External Fixator ## Common Name: External Fixator ## Classification Name: **Description and Indications:** The Berlin External Fixator is a wire connected ring or frame fixator. It can be used as a static fixator or dynamically applying distraction or compression. The Berlin Fixator has been designed as a modular construction system. Through the use of a few individual components, simple static fixation procedures can be achieved. The range of indications includes treatment of acute fractures and reconstructive surgery of all long bones. This device is made from a combination of aluminum and stainless steel. **Comparable Features to Predicate Device(s):** This device is similar in indications and characteristics to the Ilizarov device marketed by Smith-Nephew Richards. **Test Results:** Three different assemblies of the Berlin Fixator, along with the Ilizarov fixator, were tested in static and dynamic compression. The Berlin Fixator test assemblies consisted of the small, medium and large diameter rings. This testing showed that the static load to failure for the Berlin and Ilizarov fixators was the same, i.e. 600 N. At a maximum cyclic load of 300 N the three Berlin Fixator assemblies survived 226,000, 194,000 and 253,000 cycles. This compared to the Ilizarov at 346,000 cycles.