FlexitSystem Knee osteotomy system

K212545 · Neosteo · HRS · Feb 11, 2022 · Orthopedic

Device Facts

• Record ID: K212545
• Device Name: FlexitSystem Knee osteotomy system
• Applicant: Neosteo
• Product Code: HRS · Orthopedic
• Decision Date: Feb 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FlexitSystem® plates and screws system is indicated for proximal tibial and distal femoral osteotomies.

Device Story

FlexitSystem® Knee Osteotomy System consists of titanium alloy plates and locking screws; used to maintain opening and closing wedge osteotomies of proximal tibia and distal femur. Implants are surgically implanted by orthopedic surgeons in a clinical/OR setting to provide bone fixation. Fixation is achieved via threaded interface between plate holes and screws. System provides mechanical stability to bone segments during healing. Benefits include structural support for osteotomy procedures.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical mechanical testing, including static and dynamic compressive tests, torsional properties, and driving torque tests per ASTM F543, as well as pyrogenicity testing per ANSI/AAMI ST72:2011.

Technological Characteristics

Materials: Titanium alloy per ISO 5832-3 / ASTM F136. Design: Metallic plates and locking screws. Fixation: Threaded locking mechanism. Sterilization: Provided sterile.

Indications for Use

Indicated for patients requiring proximal tibial or distal femoral osteotomies.

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

• Tomofix® small stature (K100676)
• Surfix® Knee osteotomy system (K041601)
• TomoFix Osteotomy System (K023941)
• TomoFix Medial Distal Femur Plates (K081353)

Reference Devices

• ActivMotion Range (K173746)

Submission Summary (Full Text)

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February 11, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Neosteo % J.D. Webb Official Correspondent The Orthomedix Group, Inc. 4314 W. 3800 S. West Haven, Utah 84401

Re: K212545

Trade/Device Name: FlexitSystem® Knee 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: HRS. HWC Dated: January 12, 2022 Received: January 18, 2022

Dear J.D. Webb:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K212545

### Device Name

FlexitSystem® Knee Osteotomy system

Indications for Use (Describe)

The FlexitSystem® plates and screws system is indicated for proximal tibial and distal femoral osteotomies.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Neosteo Efficient Mobility. The logo consists of an orange spiral design on the left and the company name on the right. The spiral design is made up of a series of orange lines and dots, and the company name is written in orange sans-serif font, with the words "EFFICIENT MOBILITY" in smaller letters below.

## 510(k) Summary

### SUBMITTER'S INFORMATION l.

## A 510(k) Owner

NEOSTEO

Mallève 2A

1 Boulevard

Jean Moulin 44

100 Nantes,

France

Tel: [phone]

Fax: [phone]

## B Contact Person

JD Webb The Orthomedix Group, Inc. 4314 W. 3800 S. West Haven, UT 84401 Tel: [phone] Email: [e-mail]

C Date of Preparation of the 510(k) Summary

11th February 2022

### II. DEVICE IDENTIFICATION

| Trade or proprietary name | FlexitSystem® Knee osteotomy system |
|---------------------------|----------------------------------------------------------------|
| Common or usual name | FlexitSystem® plates and screws |
| Classification regulation | 21 CFR 888.3030 (plates) [primary]<br>21 CFR 888.3040 (screws) |
| Proposed Regulatory Class | Class II |
| Panel | 87 “Orthopedic” |
| Product code | HRS [primary]<br>HWC |

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Image /page/4/Picture/0 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left and the word "neosteo" in orange on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller font, also in orange. The spiral design is made up of a series of orange dots connected by lines.

# 510(k) Summary

| Primary Predicate Device | Tomofix® small stature (K100676) from Synthes USA |
|------------------------------|---------------------------------------------------------------------|
| Additional Predicate Devices | Surfix® Knee osteotomy system (K041601) from Surfix Technologies SA |
| | TomoFix Osteotomy System(K023941) from Synthes USA. |
| | TomoFix Medial Distal Femur Plates (K081353) from Synthes USA. |
| Reference device | ActivMotion Range (K173746) from Newclip Technics |

### lll. DEVICE DESCRIPTION

The FlexitSystem® Knee osteotomy system range consists of metallic surgical devices intended to maintain opening and closing wedge osteotomies of the proximal tibia and distal femur. They are available in several lengths and shapes. A FlexitSystem® Knee osteotomy system consistsof:

- -A Neosteo plate;
- -Neosteo screws that are locked into the

plate. All the implants are made of titanium alloy.

Fixation of the plate is ensured by the threading of the holes in the plate and the corresponding threads on the screws for a complete fixation of the implant.

## A. Materials

Titanium alloy per ISO 5832-3 / ASTM F136.

### IV. INDICATIONS FOR USE

FlexitSystem® plates and screws system is indicated for proximal tibial and distal femoral osteotomies.

| Intended Use | The FlexitSystem® Knee osteotomy system and all the predicates have<br>similar intended uses. |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Materials | The FlexitSystem® Knee osteotomy system is fabricated of the same or<br>similar material as the predicate devices. |
| Design<br>Features/Functions | The FlexitSystem® Knee osteotomy system and the cited predicate devices<br>share similar basic design features and functions. |
| Dimensions | The FlexitSystem® Knee osteotomy system is dimensionally similar to the<br>cited predicate devices. |

### V. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS / SUBSTANTIAL EQUIVALENCE

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Image /page/5/Picture/0 description: The image shows the logo for Neosteo Efficient Mobility. The logo consists of an orange spiral design on the left, followed by the word "neosteo" in orange. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller, sans-serif font, also in orange. The spiral design appears to be made up of a series of dots connected by lines.

# 510(k) Summary

| Sterilization | The FlexitSystem® Knee osteotomy system is provided sterile as are the<br>cited predicate devices. |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Specification | Mechanical testing confirmed the FlexitSystem® Knee osteotomy system<br>demonstrated as good or better performances than the cited predicate<br>devices under the same test conditions. |

### VI. NON-CLINICAL TEST SUMMARY

The following mechanical tests were performed:

- a. Static compressive test
- b. Dynamic compressive test
- c. Torsional properties test per ASTM F543
- d. Driving torque test per ASTM F543
- e. Pyrogenicity testing per ANSI/AAMI ST72:2011

The results of these tests indicate that the FlexitSystem® Knee osteotomy system is as strong or stronger than predicate devices.

### VII. CLINICAL TEST SUMMARY

No clinical studies were performed.

### CONCLUSIONS NON-CLINICAL AND CLINICAL VIII.

NEOSTEO considers the FlexitSystem® Knee osteotomy system to be equivalent to the predicate devices listed above. This conclusion is based on the devices' similarities in principles of operation, technology, materials and indications for use.