The Xpert Wrist range consists of plates and screws, designed for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults. The implants of the Xpert Wrist range will be provided non sterile for sterilization by health care professionals prior to use, or provided sterile by gamma sterilization. The instruments of the Xpert Wrist range will be provided non sterile for sterilization by health care professionals prior to use. Materials: CP Titanium (conform to ASTM F67 and ISO 5832-2) and Titanium alloy Ti-6AI-4V ELI (conform to ASTM F136 and ISO 5832-3). Function: The implants of the Xpert Wrist range are intended for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults.

AI/ML Overview

This FDA 510(k) summary is for a medical device called "Xpert Wrist," which consists of plates and screws for fixing hand and forearm fractures, osteotomies, and arthrodeses in adults.

The document explicitly states: "No clinical studies were performed." This means that the device was not evaluated through a study to prove its acceptance criteria in the typical sense of measuring device performance against clinical outcomes or human reader performance.

Instead, the substantial equivalence to predicate devices is based on non-clinical tests comparing the Xpert Wrist to previously cleared devices.

Here's an breakdown of the information requested, based only on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a GHTF Type A submission (based on substantial equivalence to predicate devices and no clinical studies), the acceptance criteria are based on mechanical properties being comparable or superior to the predicate devices. The document does not provide specific numerical acceptance criteria (e.g., minimum bending strength in N-mm) or exact performance values from the tests in an easily digestible table format. It states that the analysis "showed that the Xpert Wrist range is substantially equivalent to cleared predicates."

However, we can infer the types of performance assessed:

Performance Metric (Type of Test)	Acceptance Criteria (Inferred)	Reported Device Performance
Bending Strength (4-point-bending per ASTM F382)	Comparable or superior to predicate devices.	"the analysis showed that the Xpert Wrist range is substantially equivalent to cleared predicates."
Torsional Strength (ASTM F543)	Comparable or superior to predicate device screws.	"the analysis showed that the Xpert Wrist range is substantially equivalent to cleared predicates."
Axial Pull-out Strength (Chapman equation, FDA-Guidance)	Comparable or superior to predicate device screws.	"the analysis showed that the Xpert Wrist range is substantially equivalent to cleared predicates."
Endotoxin Levels (LAL quantitative kinetic chromogenic method)	Acceptable levels for medical devices.	"Endotoxin testing is performed..." (Implied acceptable results for substantial equivalence)

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

Test Set Sample Size: Not explicitly stated. The non-clinical tests would involve a certain number of manufactured plates and screws (e.g., n=5 or n=10 per test for mechanical testing).
Data Provenance: Not applicable in the context of human studies. For mechanical testing, the "data provenance" would refer to tests conducted in a laboratory setting, likely by the manufacturer or a contracted testing facility. No country of origin for the mechanical test data is specified. The tests are non-clinical and conducted to support substantial equivalence.

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

Not applicable. No clinical studies were performed, and thus no expert ground truth for a clinical test set was established. The "ground truth" here is based on established engineering standards for mechanical performance.

4. Adjudication Method for the Test Set

Not applicable. No clinical studies were performed, and thus no adjudication method for a clinical test set was used.

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

No. The document explicitly states: "No clinical studies were performed."

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

Not applicable. This is a physical medical device (plates and screws), not an AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" refers to established engineering standards (e.g., ASTM F382, ASTM F543) and comparative data from legally marketed predicate devices. The performance of the Xpert Wrist was compared against these benchmarks to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. This is not an AI/machine learning device, so there is no "training set" or ground truth for it.

Summary

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November 24, 2021

Newclip Technics % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401

Re: K213214

Trade/Device Name: Xpert Wrist 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: September 23, 2021 Received: September 29, 2021

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.

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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 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali -S

Shumaya Ali, MPH 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) K213214

Device Name Xpert Wrist

Indications for Use (Describe)

The implants of the Xpert Wrist range are intended for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K213214

Image /page/3/Picture/1 description: The image is a logo for a company called "NEWCLIP-TECHNICS". The logo features the letters "nct" in a stylized font, with a red arrow pointing upwards above the "t". The letters are enclosed in a black circle. The company name is written in all caps below the circle.

510 (k) Summary for the Xpert Wrist range

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Xpert Wrist range.

Summary preparation date: Auqust, 2021

1. Submitter:

Contact Person:

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

J.D. Webb The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven. UT 84401 Telephone: 512-590-5810

1. Trade name: Xpert Wrist Common Name: Plate, Fixation, Bone / Screw, Fixation, bone Product code: HRS - Plate, Fixation, Bone (primary) HWC - Screw, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and accessories. (21 CFR part. 888.3030) (primary) Smooth or threaded metallic bone fixation fastener.(21 CFR part. 888.3040)

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Image /page/4/Picture/1 description: The image shows a logo for a company called NEWCLIP-TECHNICS. The logo consists of the letters "nct" inside of a circle. The "t" in "nct" has an upward-pointing arrow as part of the letter. The arrow is colored in a dark pink color.

3. Primary predicate or legally marketed devices which are substantially equivalent:

Alians Fragment Specific of Newclip Technics (K170843) .

Additional predicate or legally marketed devices which are substantially equivalent:

Trimed Bone Plates of Trimed (K060041),
Synthes (USA) LCP Wrist Fusion Plates of Synthes (K042355),
APTUS® Wrist 2.5 System of Medartis (K142906 and K172170), ●
APTUS Titanium Fixation System of Medartis (K051567),
Skeletal Dynamics Protean Fraqment Plate System (K140372),
Geminus Volar Distal Radius Plate System (K182492). ●
Acumed Wrist Spanning Plate (K131764). ●
Activ Ankle of Newclip Technics (K143061 and K173641), ●
o High Tibial Osteotomy System of Newclip Technics (K141548)

4. Description of the device: The Xpert Wrist range consists of plates and screws, designed for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults. The implants of the Xpert Wrist range will be provided non sterile for sterilization by health care professionals prior to use, or provided sterile by gamma sterilization. The instruments of the Xpert Wrist range will be provided non sterile for sterilization by health care professionals prior to use. Materials: CP Titanium (conform to ASTM F67 and ISO 5832-2) and Titanium alloy Ti-6AI-4V ELI (conform to ASTM F136 and ISO 5832-3). Function: The implants of the Xpert Wrist range are intended for the fixation of hand and forearm

fractures, osteotomies and arthrodeses in adults.

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Image /page/5/Picture/0 description: The image shows a logo for Newclip-Technics. The logo consists of a circle with the letters "nct" inside. The "t" has an upward-pointing arrow as part of the letter and is colored in red. Below the circle, the words "NEWCLIP-TECHNICS" are written in a sans-serif font.

5. Substantial equivalence claimed to predicate devices:

The Xpert Wrist is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance,

6. Intended use:

The implants of the Xpert Wrist range are intended for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults.

7. Summary of the technological characteristics compared to predicate

Intended Use

The implants of the Xpert Wrist range are intended for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults.

Material

The Xpert Wrist range uses the same material as the predicate devices.

Design

The Xpert Wrist range and the predicates are equivalent in terms of shape, material, and operating principles.

Sizes

The Xpert Wrist range and the predicates are equivalent in their dimensions.

8. Non-clinical Test Summary:

The following tests were conducted:

4-point-bending tests per ASTM F382 were conducted to compare the bending strength of the subject device plates to the predicates.
ASTM F543 torsional testing was performed on the subject screws.
Equation described by Chapman for axial pull-out strength was performed on the subject screws (FDA-Guidance: Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway-2020).
Endotoxin testing is performed using LAL quantitative kinetic chromogenic method.

The analysis showed that the Xpert Wrist range is substantially equivalent to cleared predicates.

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Image /page/6/Picture/0 description: The image shows the logo for NEWCLIP-TECHNICS. The logo consists of a circle with the letters "nc" inside, with a red arrow pointing upwards above the "c". Below the circle, the words "NEWCLIP-TECHNICS" are written in a simple, sans-serif font.

9. Clinical Test Summary:

No clinical studies were performed.

10. Conclusions Non-clinical and clinical:

Based on the indications for use, technological characteristics, and the summary of data submitted, Newclip Technics determined that the Xpert Wrist range is substantially equivalent to the cleared predicate devices listed above.

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.