(183 days)
No
The device description and performance studies focus solely on the mechanical properties and fixation capabilities of the metallic plates and screws. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a metallic surgical implant intended to maintain osteotomies, which is a therapeutic intervention to correct bone deformities or address joint pain.
No
The device is a surgical implant (plates and screws) used to maintain osteotomies, not to diagnose a medical condition.
No
The device description explicitly states it consists of metallic surgical devices (plates and screws) made of titanium alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "proximal tibial and distal femoral osteotomies," which are surgical procedures performed directly on the patient's body.
- Device Description: The device is described as "metallic surgical devices intended to maintain opening and closing wedge osteotomies." These are implants used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The FlexitSystem® plates and screws system is indicated for proximal tibial and distal femoral osteotomies.
Product codes
HRS, HWC
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 consists of:
- -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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal tibial and distal femoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
No clinical studies were performed.
Key Metrics
Mechanical testing confirmed the FlexitSystem® Knee osteotomy system demonstrated as good or better performances than the cited predicate devices under the same test conditions.
Predicate Device(s)
K100676, K041601, K023941, K081353
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: +33 (0)2 36 56 96 70
Fax: +33 (0)2 51 70 61 34
B Contact Person
JD Webb The Orthomedix Group, Inc. 4314 W. 3800 S. West Haven, UT 84401 Tel: 512 590 5810 Email: jdwebb@orthomedix.net
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] |
| 21 CFR 888.3040 (screws) | |
| Proposed Regulatory Class | Class II |
| Panel | 87 “Orthopedic” |
| Product code | HRS [primary] |
| 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
similar intended uses. |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Materials | The FlexitSystem® Knee osteotomy system is fabricated of the same or
similar material as the predicate devices. |
| Design
Features/Functions | The FlexitSystem® Knee osteotomy system and the cited predicate devices
share similar basic design features and functions. |
| Dimensions | The FlexitSystem® Knee osteotomy system is dimensionally similar to the
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
cited predicate devices. |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Specification | Mechanical testing confirmed the FlexitSystem® Knee osteotomy system
demonstrated as good or better performances than the cited predicate
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.