This 510(k) summary describes a device called the EBI® DynaFix® VS™ Osteotomy System. This submission is for the addition of new plate sizes to an already marketed device. As such, the 510(k) focuses on demonstrating substantial equivalence to the predicate device, rather than providing a performance study with detailed acceptance criteria and reported device performance in the same way a novel device might.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific quantitative acceptance criteria (e.g., tensile strength, fatigue life) or corresponding reported device performance for the new plate sizes. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Intended Use	The new plate sizes must have the same intended use as the predicate device.	"The EBI DynaFix VS Osteotomy System is substantially equivalent to the predicate device in regards to intended use..."
Material	The new plate sizes must be manufactured from the same material(s) as the predicate device.	"The components of the System are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136." (Same as predicate)
Function	The new plate sizes must function in a similar manner to the predicate device for fixation following acute corrective opening wedge osteotomies in long bone. This implicitly covers mechanical properties, biocompatibility, etc. at a similar performance level.	"The EBI DynaFix VS Osteotomy System is substantially equivalent to the predicate device in regards to... function."
Design Characteristics	The design of the new plate sizes should not introduce any significant differences that would raise new questions of safety or effectiveness compared to the predicate. (The key difference here is simply added sizes).	"There are no significant differences between the modified EBI DynaFix® VS™ Osteotomy System and the currently marketed System."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable in the context of this 510(k). This submission is for additional sizes of an existing device, and the method of demonstrating safety and effectiveness relies on substantial equivalence to a predicate, not a new performance study with a test set of data.
Data Provenance: Not applicable. No new clinical or performance data is presented for a "test set" in this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. As described above, there is no performance study with a test set requiring expert ground truth establishment.

4. Adjudication Method:

Not applicable. No performance study requiring adjudication is presented.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a medical device (bone plate), not an AI or imaging diagnostic device where MRMC studies are typically performed.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

Not applicable. No new performance data requiring ground truth is presented. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device.

8. Sample Size for the Training Set:

Not applicable. There is no training set mentioned, as this is a physical medical device, not an AI or machine learning model.

9. How the Ground Truth for the Training Set was Established:

Not applicable. See point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) submission process itself, demonstrating substantial equivalence to a legally marketed predicate device.

Predicate Device: EBI® DynaFix® VS™ Osteotomy System (K010551)
Methodology: The submission asserts that the modified EBI DynaFix® VS™ Osteotomy System (with added plate sizes) is "substantially equivalent" to its predicate based on the following:
- Identical Intended Use: Both the current and predicate device are intended for "fixation following acute corrective opening wedge osteotomies in long bone."
- Identical Materials: Both are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.
- Similar Function and Technological Characteristics: The document explicitly states, "There are no significant differences between the modified EBI DynaFix® VS™ Osteotomy System and the currently marketed System. The EBI DynaFix VS Osteotomy System is substantially equivalent to the predicate device in regards to intended use, material, and function."
Conclusion: The FDA reviewed the submission and concurred with the claim of substantial equivalence, allowing the device to be marketed. This regulatory determination implicitly confirms that the device, with its new plate sizes, is considered as safe and effective as the predicate device.

Summary

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AUG 1 2 2002

510(k) Summary

KO217

This 510(k) Summary for the EBI® DynaFix® VS™ Osteotomy System is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.

1. Sponsor:EBI, L.P.100 Interpace ParkwayParsippany, NJ 07054	Contact Person: Jon Caparotta, RACTelephone: (973) 299-9300, ext.3964
Date Prepared:	May 24, 2002
2. Proprietary Name:	EBI® DynaFix® VSTM Osteotomy System
Common Name:	Bone Plate and Accessories
Classification Name:	Single/Multiple Component Metallic Bone FixationAppliances and Accessories, 21 CFR 888.3030.

3. Predicate or Legally Marketed Devices:

EBI® DynaFix® VSTM Osteotomy System (K010551) .

4. Description of Device:

The System consists of an osteotomy plate and bone screws. This submission is for the addition of plate sizes.

5. Intended Use:

The EBI DynaFix® VS™ Osteotomy System is intended for fixation following acute corrective opening wedge osteotomies in long bone.

6. Materials:

The components of the System are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.

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

There are no significant differences between the modified EBI DynaFix® VS™ Osteotomy System and the currently marketed System. The EBI DynaFix VS Osteotomy System is substantially equivalent* to the predicate device in regards to intended use, material, 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 marketed without pre-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.)]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2002

Mr. Jon Caparotta, RAC Manager, Regulatory Affairs EBI. L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K021749

Trade/Device Name: EBI® DynaFix® VS™ Osteotomy System Regulation Number: 21 CFR §888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: NDF and NDH Dated: May 24, 2002 Received: May 28, 2002

Dear Mr. Caparotta;

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, 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 (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.

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Page 2 - Mr. Jon Caparotta, RAC

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 531-542 of the Act); 21 CFR 1000-1050.

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 your 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 A. Millman

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

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Statement of Indications for Use

Page 1 of 1

510(k) Number.(if known):

Device Name: EBI® DynaFix® VSTM Ostcotomy System

Indications For Use:

The EBI® DynaFix® VS™ Osteotomy System is intended for fixation following acute corrective opening wedge osteotomies in long bone.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-The-Counter Use

(Per 21 CFR 801.109) (Optional Format 1-2-96)

signature

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

510(k) Number	K021749
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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.