(56 days)
Not Found
No
The summary describes a range of bone plates and screws for fracture fixation, osteotomies, and arthrodeses. There is no mention of AI, ML, image processing, or any software-based functionality that would typically incorporate these technologies. The performance studies are mechanical tests of the implants.
Yes.
The device is intended for the fixation of hand and forearm fractures, osteotomies, and arthrodeses, which are medical conditions that require treatment to restore function and mitigate pain.
No
This device is an implantable plate and screw system designed for the fixation of bone fractures, osteotomies, and arthrodeses, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it consists of plates and screws made of CP Titanium and Titanium alloy, which are hardware components. The performance studies also focus on mechanical properties of these physical implants.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of hand and forearm fractures, osteotomies and arthrodeses in adults." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of "plates and screws" made of titanium, which are implants used for internal fixation.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
This device is an implantable surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The implants of the Xpert Wrist range are intended for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults.
Product codes
HRS, HWC
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and forearm
Indicated Patient Age Range
adults
Intended User / Care Setting
health care professionals
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:
- 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.
Clinical Test Summary:
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
K170843, K060041, K042355, K142906, K172170, K051567, K140372, K182492, K131764, K143061, K173641, K141548
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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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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
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- 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.