(92 days)
No.
The device description outlines plates and screws for fracture fixation, with no mention of AI, machine learning, or image processing capabilities. The performance studies are non-clinical engineering and comparative tests, not involving AI models.
No.
The device, consisting of plates and screws, is used for the fixation of fractures, non-unions, and malunions of the proximal tibia. While it aids in the healing process of injuries, its primary function is structural support and stabilization, not direct therapeutic action in the sense of treating a disease or disorder through chemical or physical means.
No
The device is described as implants (plates and screws) intended for the fixation of fractures, non-unions, and malunions of the proximal tibia. This is a therapeutic function, not a diagnostic one.
No
The device is described as a range of plates and screws made from titanium materials, intended for the fixation of fractures in the proximal tibia. These are physical implants and instruments, not software. The performance studies also refer to engineering analysis and comparative static and dynamic tests on physical plates and screws.
No
This device is an orthopedic implant for fixing fractures, non-unions, and malunions of the proximal tibia, which is an in-vivo diagnostic/therapeutic purpose, not an in-vitro diagnostic purpose.
N/A
Intended Use / Indications for Use
The implants of Xpert Knee range are indicated for the fixation of fractures, non-unions and malunions of the proximal tibia in adults.
Product codes
HRS, HWC
Device Description
The Xpert Knee range consists of plates and screws designed for the fixation of fractures, nonunions and malunions of the proximal tibia in adults.
The plates and screws of the Xpert Knee range will be provided sterile by gamma sterilization or non-sterile for sterilization by health care professionals prior to use.
The instruments of the Xpert Knee range will be provided non sterile for sterilization by health care professionals prior to use.
Materials: CP Titanium grade 4 (conform to ASTM F67 and ISO 5832-2) for the plates, and Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3) for the screws.
Function: The implants of Xpert Knee range are indicated for the fixation of fractures, non-unions and malunions of the proximal tibia in adults.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal tibia
Indicated Patient Age Range
adults.
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
Non-clinical Test Summary:
The following tests were conducted:
- Engineering analysis and comparative static and dynamic tests were performed on the plates, according to ASTM F382.
- Engineering analysis regarding pullout strength and comparative torsional test were performed on the screws, according to ASTM F543.
The analysis showed that the Xpert Knee range is substantially equivalent to cleared predicates.
Clinical Test Summary:
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
K120689, K050646, K082624, K011978 / K030597
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.
FDA 510(k) Clearance Letter - Xpert Knee
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 24, 2025
Newclip Technics
℅ J.D. Webb
President
The OrtoMedix Group, Inc.
4313 W. 3800 S.
West Haven, Utah 84401
Re: K250155
Trade/Device Name: Xpert Knee
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 15, 2025
Received: January 21, 2025
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 (the 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 available 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.
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K250155 - J.D. Webb Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250155 - J.D. Webb Page 3
assistance/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,
CHRISTOPHER FERREIRA -S
Christopher Ferreira, M.S.
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K250155
Device Name
Xpert Knee
Indications for Use (Describe)
The implants of Xpert Knee range are indicated for the fixation of fractures, non-unions and malunions of the proximal tibia in adults.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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K250155 - Page 1 of 1
Page 5
K250155 510(k) Summary - Xpert Knee
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Xpert Knee range.
1. Submitter and Contact Person
Submitter:
NEWCLIP TECHNICS
P.A. de la Lande Saint Martin
45 rue des Garottières
F-44115 Haute-Goulaine - France
Telephone: (33) 2 28 21 37 12
Contact Person:
J.D. Webb
The OrthoMedix Group, Inc.
4313 W. 3800 S.
West Haven. UT 84401
Telephone: 512-590-5810
2. Device Information
Trade name: Xpert Knee
Common Name: Plate, Fixation, Bone / Screw, Fixation, bone
Product code:
- HRS - Plate, Fixation, Bone
- HWC - Screw, Fixation, Bone
Classification Name:
- Single/multiple component metallic bone fixation appliances and accessories. (21 CFR part. 888.3030)
- Smooth or threaded metallic bone fixation fastener.(21 CFR part. 888.3040)
K250155 - Page 1 of 3
Page 6
3. Primary predicate or legally marketed devices which are substantially equivalent:
- DEPUY SYNTHES 3.5 mm VA LCP® Proximal Tibia Plate System (K120689) - Primary Predicate Device
- DEPUY SYNTHES 3.5 mm LCP® Medial Proximal Tibia Plates (K050646) - Additional Predicate Device
- DEPUY SYNTHES 3.5 mm LCP® Proximal Tibia Plates (K082624) - Additional Predicate Device
- DEPUY SYNTHES 3.5 mm LCP® Proximal Tibia Plates (K011978 / K030597) - Additional Predicate Device
Reference devices:
- Newclip Technics Footmotion Plating System range (K221395)
- Newclip Technics Activmotion S (K241539)
- Newclip Technics Activmotion (K173746)
4. Description of the device:
The Xpert Knee range consists of plates and screws designed for the fixation of fractures, nonunions and malunions of the proximal tibia in adults.
The plates and screws of the Xpert Knee range will be provided sterile by gamma sterilization or non-sterile for sterilization by health care professionals prior to use.
The instruments of the Xpert Knee range will be provided non sterile for sterilization by health care professionals prior to use.
Materials: CP Titanium grade 4 (conform to ASTM F67 and ISO 5832-2) for the plates, and Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3) for the screws.
Function: The implants of Xpert Knee range are indicated for the fixation of fractures, non-unions and malunions of the proximal tibia in adults.
5. Technological characteristics and substantial equivalence
The Xpert Knee range has the same or similar technological characteristics of the predicate devices.
K250155 - Page 2 of 3
Page 7
The Xpert Knee range has the same or similar technological characteristics of the predicate devices.
6. Indication for use
The implants of Xpert Knee range are indicated for the fixation of fractures, non-unions and malunions of the proximal tibia in adults.
7. Summary of the technological characteristics compared to predicate
Indication for use
The implants of Xpert Knee range are indicated for the fixation of fractures, non-unions and malunions of the proximal tibia in adults.
Material
The Xpert Knee range uses the same material as the primary predicate devices.
Design
The Xpert Knee range and the predicates are substantially equivalent in terms of shape, and operating principles.
Sizes
The Xpert Knee range and the predicates are substantially equivalent in their dimensions.
8. Non-clinical Test Summary:
The following tests were conducted:
- Engineering analysis and comparative static and dynamic tests were performed on the plates, according to ASTM F382.
- Engineering analysis regarding pullout strength and comparative torsional test were performed on the screws, according to ASTM F543.
The analysis showed that the Xpert Knee range is substantially equivalent to cleared predicates.
9. Clinical Test Summary:
No clinical studies were performed.
10. Conclusions Non-clinical and clinical:
The Xpert Knee range is as safe, as effective, and performs as well or better than the legally marketed devices identified above.
K250155 - Page 3 of 3