(268 days)
No
The document describes a mechanical implant system for wrist replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for the replacement of wrist joints to alleviate pain, deformity, and limited motion caused by various conditions, and aims to restore functionality and mobility of the wrist joints. These are therapeutic effects.
No
The device is an implantable total wrist arthroplasty system used for joint replacement, not for diagnosing a condition.
No
The device description clearly states it is an implant system consisting of physical components (radial implant assembly and carpal implant assembly) made of materials like CoCr and UHMWPE, intended for surgical implantation. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the replacement of wrist joints. This is a surgical implant, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details the components of a surgical implant (radial implant assembly, carpal implant assembly) designed to be implanted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a therapeutic device used to surgically replace a damaged joint.
N/A
Intended Use / Indications for Use
The KinematX Total Wrist Arthroplasty System is indicated for the replacement of wrist joints disabled by pain, deformity, and/or limited motion caused by:
- Non-inflammatory degenerative wrist disease of the radiocarpal joint including osteoarthritis, post-traumatic arthritis, and Kienbock's disease
- Revision where other devices or treatments have failed
-
- Scapholunate Advanced Collapse (SLAC)
- Rheumatoid Arthritis
The device is intended to be implanted with bone cement.
Product codes
JWJ
Device Description
The KinematX Total Wrist Arthroplasty System is a semi-constrained implant system designed to replace the joints of the wrist to alleviate pain while restoring functionality and mobility of the wrist joints. The system consists of two main, modular components:
- Radial Implant Assembly: CoCr radial stem and an ultra-high molecular weight polyethylene (UHMWPE) bearing surface that interlocks onto a CoCr tray
- Carpal Implant Assembly: Baseplate with central peg, index metacarpal screw, hamate screw, and CoCr cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist joints
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
No clinical testing was performed.
Non-clinical Testing:
Specific testing performed on the KinematX device include:
• Axial Compression Test
• Construct Moment Bend Fatigue Test
• Taper Disassembly Testing
• Constraint Testing
• Assembly Torsion Testing
• Screw mechanical testing evaluation
• Cadaveric evaluation
• Pyrogenicity testing
Key Metrics
Not Found
Predicate Device(s)
K042032, Maestro Total Wrist, Biomet, Inc.
K132250, Freedom Wrist Arthroplasty System, Integra Life Sciences Corporation
K021859, Remotion Total Wrist, Stryker
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
March 04, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
Extremity Medical, LLC. Brian Smekal VP, Regulatory Affairs and Quality Assurance 300 Interpace Parkway, Suite 410 PARSIPPANY, NJ 07054
Re: K191525
Trade/Device Name: KinematX Total Wrist Arthroplasty System Regulation Number: 21 CFR 888.3800 Regulation Name: Wrist joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWJ Dated: January 31, 2020 Received: January 31, 2020
Dear Brian Smekal:
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 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
1
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,
Michael C. Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191525
Device Name
KinematX Total Wrist Arthroplasty System
Indications for Use (Describe)
The KinematX Total Wrist Arthroplasty System is indicated for the replacement of wrist joints disabled by pain, deformity, and/or limited motion caused by:
-
Non-inflammatory degenerative wrist disease of the radiocarpal joint including osteoarthritis, post-traumatic arthritis, and Kienbock's disease
-
Revision where other devices or treatments have failed
-
- Scapholunate Advanced Collapse (SLAC)
- Rheumatoid Arthritis
The device is intended to be implanted with bone cement.
| 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)
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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510(k) Summary of Safety and Effectiveness:
KinematX Total Wrist Arthroplasty System
| Submitter | Extremity Medical, LLC.
300 Interpace Parkway, Suite 410
Parsippany, NJ 07054 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Smekal, MS, RAC
VP, Regulatory Affairs and Quality Assurance
Phone: (973) 588-8988
Email: bsmekal@extremitymedical.com |
| Date Prepared | March 4, 2020 |
| Trade Name | KinematX Total Wrist Arthroplasty System |
| Classification
Name and Number | 21 CFR 888.3800: Wrist joint metal/polymer semi-constrained cemented prosthesis |
| Product Code | JWJ |
| Common Name | Total Wrist Replacement Device |
| Predicate Devices | K042032, Maestro Total Wrist, Biomet, Inc.
K132250, Freedom Wrist Arthroplasty System, Integra Life Sciences Corporation
K021859, Remotion Total Wrist, Stryker |
| Device Description | The KinematX Total Wrist Arthroplasty System is a semi-constrained implant system
designed to replace the joints of the wrist to alleviate pain while restoring functionality
and mobility of the wrist joints. The system consists of two main, modular components:
Radial Implant Assembly: CoCr radial stem and an ultra-high molecular weight
1)
polyethylene (UHMWPE) bearing surface that interlocks onto a CoCr tray
Carpal Implant Assembly: Baseplate with central peg, index metacarpal screw,
2)
hamate screw, and CoCr cap. |
| Indications for use | The KinematX Total Wrist Arthroplasty System is indicated for the replacement of wrist
joints disabled by pain, deformity, and/or limited motion caused by:
- Non-inflammatory degenerative wrist disease of the radiocarpal joint including
osteoarthritis, post-traumatic arthritis, and Kienbock's disease - Revision where other devices or treatments have failed
- Scapholunate Advanced Collapse (SLAC)
- Rheumatoid Arthritis
The device is intended to be implanted with bone cement. |
| Statement of
Technological
Comparison | The KinematX Total Wrist Arthroplasty System is equivalent to predicate device Biomet
Maestro in terms of indications for use, material design (i.e, distal metal and proximal
polyethylene articulating surfaces), and material mechanical properties. The KinematX
Total Wrist Arthroplasty is equivalent to the predicate device Integra Freedom in
indications for use, materials and range of motion. The modular design of the KinematX
tapers is equivalent to the predicate Maestro. |
| Non-clinical
Testing | Specific testing performed on the KinematX device include:
•
Axial Compression Test
• Construct Moment Bend Fatigue Test
• Taper Disassembly Testing
• Constraint Testing
• Assembly Torsion Testing
• Screw mechanical testing evaluation
• Cadaveric evaluation
• Pyrogenicity testing |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The KinematX Total Wrist Arthroplasty System is substantially equivalent to its
predicate device. This conclusion is based upon indications for use, principles of
operation, design, and mechanical test data. |
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