← Product Code [LXT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT) · K954053 # BERLIN EXTERNAL FIXATOR (K954053) _Encore Orthopedics, Inc. · LXT · May 16, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT/K954053 ## Device Facts - **Applicant:** Encore Orthopedics, Inc. - **Product Code:** [LXT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT.md) - **Decision Date:** May 16, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT/K954053](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT/K954053) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com