The EBI® XFIX® DFS® System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

Device Description

The System consists of fixation components and implantable bone screws. The EBI® XFIX® DFS® System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue, and into the bone. The fixator frame of the EBI® XFIX® DFS® System is attached to the shanks of the bone screws. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of the Hip Distracter to the System.

AI/ML Overview

This submission is a Special 510(k) Device Modification for the EBI® XFIX® DFS® Fixation System (K022319), adding a Hip Distracter. The submission relies on substantial equivalence to the predicate device, the EBI® XFIX® DFS® System (K953406).

Acceptance Criteria and Device Performance:

The document does not explicitly define acceptance criteria as a new device or a new clinical claim is not being made. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance
Material Equivalence	The modified EBI® XFIX® DFS® System is fabricated from the same materials as the components of the currently marketed EBI® XFIX® DFS® Fixation System (Aluminum, Stainless Steel, Cobalt Chrome, Carbon Fiber, and Titanium Alloy).
Intended Use Equivalence	The modified EBI® XFIX® DFS® System and the currently marketed EBI® XFIX® DFS® System are both indicated for the treatment of bone conditions, including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
Functional Equivalence of Bone Screw Clamps	The bone screw clamps of the modified EBI® XFIX® DFS® System, like the bone screw clamps currently marketed in the EBI® XFIX® DFS® System, are designed for attachment to the bone screws.
Sterilization Status Equivalence	The additional component of the EBI® XFIX® DFS® System, like the components of the currently marketed EBI® XFIX® DFS® System, is provided non-sterile.
Overall Substantial Equivalence (Intended Use, Materials, Function)	There are no significant differences between the modified EBI® XFIX® DFS® System and the currently marketed EBI® XFIX® DFS® System. It is substantially equivalent to the predicate device with regard to intended use, materials, and function. This implies that the device performs equivalently to the predicate and thus meets the safety and effectiveness profile of the predicate device, which is already legally marketed.

Study Information:

The provided document is a 510(k) summary for a device modification, not a clinical study report. Therefore, it does not describe a new clinical study with the traditional elements of acceptance criteria, sample size, ground truth, or expert review for performance evaluation. Instead, the "study" is a comparison to a legally marketed predicate device.

Sample size used for the test set and the data provenance: Not applicable. This submission is based on a comparison of device characteristics to a predicate, not a test set of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in clinical trials or diagnostic accuracy studies is not relevant here as there is no new clinical data being presented for review. The "ground truth" is established by the prior clearance of the predicate device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/software device and no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this 510(k) is the regulatory acceptance and safety/effectiveness profile of the predicate device (EBI® XFIX® DFS® System K953406). The modified device is deemed substantially equivalent based on its inherent characteristics matching those of the predicate, and therefore, it is considered safe and effective for its intended use, similar to its predicate.
The sample size for the training set: Not applicable. This is not a machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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AUG 1 2 2002

Special 510(k) Device Modification: EBI® XFIX® DFS® Fixation System

K022319
page 1 of 2

510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI® XFIX® DFS® System is provided as required per Section 513(I)(3) of the Federal Food, Drug and Cosmetic Act.

Contact Person: Frederic Testa, RAC 1. Sponsor: (973) 299-9300, ext.2208 Telephone: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054

Date Prepared: July 10, 2002

2. Proprietary Name:	EBI® XFIX® DFS® System
Common Name:	External Fixation Device
Classification Name:	Single Multiple Component Metallic Bone FixationAppliances and Accessories, 21 CFR 888.3030.

3. Predicate or Legally Marketed Device:

EBI® XFIX® DFS® System (K953406) .

4. Description of Device:

5. Intended Use:

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6. Materials:

KWD2319
page 2 of 2

The components of the System may be manufactured from materials such as Aluminum, Stainless Steel, Cobalt Chrome, Carbon Fiber, and Titanium Alloy.

7. Comparison of the technological characteristics of the device to predicate devices:

The modified EBI® XFIX® DFS® System is substantially equivalent to the following predicate device:

EBI® XFIX® DFS® System (K953406)

The modified EBI® XFIX® DFS® System is fabricated from . the same materials as the components of the currently marketed EBI® XFIX® DFS® Fixation System.
The modified EBI XFIX® DFS® System and the currently marketed EBI® . XFIX® DFS® System are both indicated for the treatment of bone conditions, including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
The bone screw clamps of the modified EBI® XFIX® DFS® System, like . the bone screw clamps currently marketed in the EBI® XFIX® DFS® System, are designed for attachment to the bone screws.
The additional component of the EBI® XFIX® DFS® System, like the . components of the currently marketed EBI® XFIX® DFS® System, is provided non-sterile.
There are no significant differences between the modified EBI® XFIX® ● DFS® System and the currently marketed EBI® XFIX® DFS® System. It is substantially equivalent* to the predicate device with regard to intended use, materials, and function.

* Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977. FR 42520 (Docket No. 76N-0355.)1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2002

Mr. Frederic Testa, RAC Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054

Re: K022319

Trade/Device Name: EBI® XFIX® DFS® System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: July 15, 2002 Received: July 17, 2002

Dear Mr. Testa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Frederic Testa, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) ( premarket notification. The FDA finding 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark McMillan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

Odd319 510(k) Number (if known): Device Name: EBI® XFIX® DFS® System

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Page

b. -Mark n Mulberin

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number --

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.