Stabilization of fractures & Osteotomy Bone deformity correction of lower extremities Arthrodesis of the rear foot, mid foot, and ankle joint. Limb lengthening in pediatric and adults.

Device Description

The Fusion Medical Ring Lock system is a Circular Frame and Footplate system, used in lower extremity Stabilization and Deformity Correction. Wires are placed in the bone and attached to the frame with wire fixation bolts. The wires are then tensioned to support the bone. Rings are made of aluminum 6061 T6. Posts are used to capture wires that are elevated off the frame. Posts are made of 17-4 PH stainless steel. Washers are used to fine tune the elevation, and hinges are used for gradual correction of bone.

AI/ML Overview

Here's an analysis of the provided information, structured to address your specific requests:

This document describes a 510(k) submission for the "Fusion Medical Ring Lock System", which is an external ring fixation device. The core of the submission is to demonstrate substantial equivalence to a predicate device, the "Vilex Frame (K052196)". The study provided is a comparative analysis, not a clinical trial with acceptance criteria for device performance in a clinical setting.

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence:
The primary acceptance criterion for this 510(k) submission is to demonstrate that the new device (Fusion Medical Ring Lock System) is substantially equivalent to a legally marketed predicate device (Vilex Frame K052196) in terms of intended use, technological characteristics, and safety and effectiveness.

Acceptance Criterion (for Substantial Equivalence)	Reported Device Performance
Intended Use: Identical or similar indications.	Identical: The Fusion Medical Ring Lock System is indicated for: Stabilization of fractures & Osteotomy, Bone deformity correction of lower extremities, Arthrodesis of the rear foot, mid foot and ankle joint, and Limb lengthening in pediatric and adults. The predicate Vilex Frame has the "same indication for use."
Technological Characteristics: Same or similar technological characteristics (design, materials, sizes).	Similar/Functionally Identical: The technological characteristics are stated to be "identical." The only design difference mentioned is that Fusion's tabs have 3 holes, while Vilex's have 2 holes. Both are made from the "same material, aluminum alloy." Sizes (140mm, 160mm, 180mm, 205mm) for the frame, as well as rod material and length, are reported as "the same." Posts are made of 17-4 PH stainless steel for Fusion, while the predicate's post material isn't explicitly stated but assumed similar due to the claim of identical characteristics.
Safety and Effectiveness: No new questions of safety or effectiveness are raised.	Demonstrated through Comparative Analysis: "Cross sectional engineering analysis shows the Fusion Medical Ring Lock system is equivalent to the Vilex Frame. There was no change to the design or size to decrease structural strengths in the rings or components and their material." This analysis implicitly concludes that the minor design difference (3 holes vs. 2 holes on tabs) does not negatively impact structural integrity or raise new safety/effectiveness concerns.

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

Test Set Sample Size: Not applicable. This submission relies on an "engineering analysis" and comparison to a predicate device, rather than a statistical test set of devices or patient data.
Data Provenance: The data provenance is from an internal "cross sectional engineering analysis" performed by the submitter (Fusion Medical Corp.). It is not explicitly stated whether this involved physical testing of multiple units or purely computational analysis, but the phrasing "cross sectional engineering analysis shows..." suggests a comparative assessment of design specifications and material properties. It is retrospective in the sense that it evaluates the design against the predicate's known characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable in the context of clinical expert consensus. The "ground truth" here is established by the engineering analysis, which would have been conducted by engineering personnel at Fusion Medical Corp. The specific number or qualifications of these engineers are not provided in the document. For a 510(k) submission, the FDA acts as the ultimate "expert" in determining if substantial equivalence is met based on the presented data.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no clinical test set requiring adjudication of findings. The decision on substantial equivalence is made by the FDA based on the information provided in the submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission focuses on demonstrating substantial equivalence of a medical device based on its physical characteristics and intended use, not on user performance or clinical outcomes that would require an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance Study: Not applicable. This device is a mechanical external fixation system, not a software algorithm or AI-driven tool. Therefore, a "standalone algorithm performance" study is not relevant.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for this submission is the established characteristics and performance of the legally marketed predicate device (Vilex Frame K052196). The submitted "engineering analysis" serves to compare the new device's characteristics against this established ground truth to argue for equivalence.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. There is no concept of a "training set" as this is not an AI/ML device or a clinical study that would involve such a set.

9. How the Ground Truth for the Training Set Was Established

Training Set Ground Truth: Not applicable, as there is no training set for this type of device submission.

Summary

{0}------------------------------------------------

K100857

John J Riccio (Fusion Medical Corp.) 44 Church St West Haven CT. 06516

Phone: (203) 823-8511 Fax: (860) 454-7562

MAY 8 7 2010

Summary Fusion Medical Ring Lock System

Date Of submission:	3/12/10
Type of submission:	510(K)
Reason for submission: New Device
Product code:	KTT, CRF-21 888.3030
Device class:	II
Classification panel:	Orthopedics
Predicate devices:K052196	Vilex
Common Name:	External Ring Fixation
Device Trade Name:	Fusion Medical Ring Lock System
Establishment Operations:	Manufacture
Indications for use:	Stabilization of fractures & OsteotomyBone deformity correction of lower extremities.Arthrodesis of the rear foot, mid foot and ankle joint.Limb lengthening in pediatric and adults.
Submitter:	John Riccio

Device Description:

p. 1 of 2

{1}------------------------------------------------

Technological Characteristics:

The technological characteristics between the Vilex Frame (K052196) and the Fusion Frame are identical, the only design difference is our tabs on the rings have 3 holes; Vilex has 2 holes on their tabs. Both are made from the same material, aluminum alloy. The Vilex Frame has the same sizes as the Fusion Frame: 140mm, 160mm, 180mm, and 205mm. Rods are the same material and length, as are other components. The Vilex xfix frame has the same indication for use.

Summary of Testing:

Cross sectional engineering analysis shows the Fusion Medical Ring Lock system is equivalent to the Vilex Frame. There was no change to the design or size to decrease structural strengths in the rings or components and their material.

Conclusion:

Fusion Medical Ring Lock System is equivalent to devices already marketed for the same indications.

p. 2 of 2.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. John J. Riccio 44 Church Street West Haven, Connecticut 06516

MAY 2 7 2010

Re: K100857

Trade/Device Name: Fusion Medical Ring Lock System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: March 12, 2010 Received: March 26, 2010

Dear Mr. Riccio:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

{3}------------------------------------------------

Page 2 - Mr. John J. Riccio

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(K) Number (if known): K100857

Device Name: Fusion Medical Ring Lock System

Indications for Use: Stabilization of fractures & Osteotomy Bone deformity correction of lower extremities Arthrodesis of the rear foot, mid foot, and ankle joint. Limb lengthening in pediatric and adults.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND /OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please Do Not Write Below This Line-Continue On Another Page Of Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ouster for mxn

(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100857

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.