EBI DFS JOINT FIXATOR, MODEL 02800

K981483 · Electro-Biology, Inc. · KTT · Jul 8, 1998 · Orthopedic

Device Facts

• Record ID: K981483
• Device Name: EBI DFS JOINT FIXATOR, MODEL 02800
• Applicant: Electro-Biology, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Jul 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EBI DFS® Joint Fixator is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external fixation modality. Possible applications include: - a) fracture dislocation with ligamentos instability; - b) comminuted intra-articular fracture; and - c) post traumatic reconstruction for joint stiffness.

Device Story

EBI DFS Joint Fixator is a unilateral external fixation system for upper extremity bone and soft tissue conditions; line extension of EBI XFIX DynaFix system. Device comprises telescoping arms, dual locking connectors, inner body rotation components, and a central elbow disc. Central elbow disc features elbow U-connector, rings, and distractor mechanism. Surgeon attaches device to bone via bone screws; distractor mechanism allows compression or distraction of articular surfaces. Optional stopping mechanisms limit joint motion. Device provides controlled flexion/extension of elbow or wrist joints. Used in clinical settings by physicians to stabilize fractures and reconstruct joints; benefits patient by minimizing trauma to anatomical structures and facilitating controlled joint movement during healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Stainless steel (ASTM A582, A582M-95A, F899), Aluminum alloy Al 6061-6 (ASTM B221), Delrin (ASTM D4181POMILL). Mechanical fixation system; unilateral design; includes telescoping arms, locking connectors, and central elbow disc with distractor mechanism. Polyethylene bushings used for ring rotation. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring upper extremity external fixation for fracture dislocation with ligamentous instability, comminuted intra-articular fractures, or post-traumatic reconstruction for joint stiffness.

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

• Orthofix Elbow Fixator

Reference Devices

• EBI XFIX DynaFix Fixation System

Submission Summary (Full Text)

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## SECTION III 981483 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness for the EBI DFS® Joint Fixator is provided as required per Section 513(1)(3) of the Food, Drug and Cosmetic Act.

## 1. Submitter:

Electro-Biology, Inc. 6 Upper Pond Road Parsippany, NJ 07054

#### 2. Date Prepared:

January 7, 1998

#### 3. Official Correspondent:

Jon Caparotta Manager, Regulatory Affairs [phone] x 3964 Telephone: [phone] Fax:

## Contact Person:

Sam Mirza

Senior Regulatory Affairs Specialist [phone] x 3318 Telephone: [phone] Fax:

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#### Proprietary Name: 3.

EBI DFS® Joint Fixator

## Common Name:

External Fixation Device

## Classification Name:

Single Multiple Component Metallic Bone Fixation Appliances and Accessories, 21 CFR 888.3030.

#### Predicate or Legally Marketed Devices: 4.

Orthofix Elbow Fixator – Orthofix Inc.

#### Description of Device: ട.

The EBI DFS® Joint Fixator is a line extension of the currently marketed The EBI DFS O Joint Fixator is EBI XFIX DynaFix Fixation System. unilateral in design and is therefore available in both left and right configurations. The major components of the EBI DFS® Joint Fixator are as follows:

- DFS® Telescoping Arm .
- DFS® Dual Locking Connector Component .
- DFS® Inner Body Female Rotation Component .
- Central Elbow Disc .
- Precision Dual Locking Connector Component .
- Precision Inner Body Female Rotation Component .
- Precision Telescoping Stem .

2016

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Please note: The DFS® Telescoping Arm, DFS® Dual Locking Connector Component, DFS® Inner Body Female Rotation Component, Precision Inner Body Female Rotation Component, Precision Dual Locking Connector and Precision Telescoping Stem are also the components of the currently marketed EBI XFIX DynaFix Fixation System.

The Central Elbow Disc is comprised of the following components:

- Elbow U-Connector .
- Elbow Rings (Outer and Inner) .
- Elbow Distractor .
- Optional Stopping Mechanisms .

The Elbow U-Connector employs a locking set screw for attachment to the inner ring of the Central Elbow Disc. The Elbow U-Connector is designed to lock the movement of the outer Elbow Ring relative to the inner Elbow Ring. The outer Elbow Ring employs a male adapter with a threaded hole for attachment to the Distraction/Compression mechanism employed by the Elbow Distractor. A polyethylene bushing is placed between the outer and the inner ring to provide ease of rotation of the rings relative to each other.

The optional Stopping Mechanism, which is attached to the inner ring via a locking set screws, limits the motion of the outer and inner, rings relative to each other, thereby, limiting joint movement. The optional Stopping Mechanisms can be positioned around the ring to provide optimal joint fixation.

The Elbow Distractor allows attachment of the DFS® Inner Body Female Rotation Component on one side and the Elbow ring on the other side. One side of the Elbow Distractor employs a male adapter for attachment to the

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female adapter of the DFS® Inner Body Female Rotation Component. The other side of the Elbow Distractor employs a female adapter for attachment to the male adapter of the Elbow Ring. The male adapter of the Elbow Distractor is connected to the female adapter of the DFS® Inner Body Female Rotation Component at an angle to provide optimal fixation of bone screws in the bone. During surgery the distractor mechanism allows either distraction or compression of the articular surfaces for optimal treatment of the joint condition.

The Elbow Distractor, Elbow rings and the Elbow U-Connector of the Central Elbow Disc would be available in a range of sizes, for use with the components of the currently marketed standard, small and extra small EBI XFIX DynaFix Fixation System, to address patients with varying bone size requirements.

The components of the EBI DFS® Joint Fixator are fabricated from the following materials, which conform to the requirements specified in the American Society of Testing and Materials (ASTM) standards:

- Stainless steel (ASTM Standards A582, A582M-95A and ASTM F899) ●
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

- Aluminum alloy Al 6061-6 ( ASTM B221) ●
- Delrin (ASTM D4181POMILL) .

#### Intended Use: 6.

The EBI DFS Joint Fixator is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external fixation modality. Possible applications include:

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- a) fracture dislocation with ligamentos instability;
- b) comminuted intra-articular fracture; and
- c) post traumatic reconstruction for joint stiffness.

#### Substantial Equivalence: 7.

The EBI DFS Joint Fixator is substantially equivalent to the following predicate device:

Orthofix Elbow Fixator - Orthofix Inc.

The features of the EBI DFS® Joint Fixator are substantially equivalent to the features of the competitive device.

Substantial equivalence of the EBI DFS® Joint Fixator to the currently marketed Orthofix Elbow Fixator is demonstrated as follows:

- The components of the EBI DFS® Joint Fixator are fabricated from the . same material as the components of the currently marketed Orthofix Elbow Fixator.
- The EBI DFS® Joint Fixator, like the predicate Orthofix Elbow Fixator, . minimizes trauma to anatomical structures by controlling flexion and extension capabilities of the elbow. In addition, the EBI DFS® Joint Fixator would be utilized for the treatment of the wrist joint.
- The EBI DFS® Joint Fixator and the currently marketed Orthofix Elbow . Fixator are both indicated for fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

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- The EBI DFS® Joint Fixator like the currently marketed Orthofix Elbow Fixator employs bone screw clamps for accommodating bone screws affixed to the bone.
- The Central Elbow Disc component of the EBI DFS® Joint Fixator like . the currently marketed Orthofix Elbow Fixator provides controlled movements of the joint.
- The EBI DFS® Joint Fixator like the currently marketed Orthofix Elbow . Fixator employs a distractor mechanism that is initially used to disimpact the articular surfaces.

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Image /page/6/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL - 8 1998

Mr. Jon Caparotta ·Manager, Regulatory Affairs Electro-Biology, Inc. 6 Upper Pond Road Parsippany, New Jersey 07054

Re: K981483 EBI DFS® Joint Fixator Trade Name: Requlatory Class: ı i Product Code: KTT Dated: April 23, 1998 Received: April 24, 1998

Dear Mr. Caparotta:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2 - Mr. Jon Caparotta

This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA assorialing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SECTION IV STATEMENT FOR INDICATIONS FOR USE

The EBI DFS® Joint Fixator is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external fixation modality. Possible applications include.

- 1. fracture dislocation with ligamentos instability;
- 2. comminuted intra-articular fracture; and
- 3. post traumatic reconstruction for joint stiffness.

**Prescription Use**
(Per 21 CFR 801.109)

ﻟﻜﺴﺎﺭ

(Division Sian-Off) Division of General Restorative Device 510(k) Number