Who is the manufacturer of KinematX Total Wrist Arthroplasty System?

Extremity Medical, LLC filed the 510(k) submission for KinematX Total Wrist Arthroplasty System (K191525).

What is the FDA product code for KinematX Total Wrist Arthroplasty System?

JWJ. It is classified under 21 CFR 888.3800 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for KinematX Total Wrist Arthroplasty System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for KinematX Total Wrist Arthroplasty System?

Maestro Total Wrist (K042032); Freedom Wrist Arthroplasty System (K132250); Remotion Total Wrist (K021859).

Who can help prepare an FDA 510(k) submission like KinematX Total Wrist Arthroplasty System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

KinematX Total Wrist Arthroplasty System

K191525 · Extremity Medical, LLC · JWJ · Mar 4, 2020 · Orthopedic

Device Facts

Record ID	K191525
Device Name	KinematX Total Wrist Arthroplasty System
Applicant	Extremity Medical, LLC
Product Code	JWJ · Orthopedic
Decision Date	Mar 4, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3800
Device Class	Class 2
Attributes	Therapeutic

Intended 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: 1. Non-inflammatory degenerative wrist disease of the radiocarpal joint including osteoarthritis, post-traumatic arthritis, and Kienbock's disease 2. Revision where other devices or treatments have failed 3. Scapholunate Advanced Collapse (SLAC) 4. Rheumatoid Arthritis The device is intended to be implanted with bone cement.

Device Story

Semi-constrained total wrist arthroplasty system; replaces wrist joints to alleviate pain and restore mobility. System comprises two modular assemblies: Radial Implant Assembly (CoCr radial stem, UHMWPE bearing surface, CoCr tray) and Carpal Implant Assembly (baseplate with central peg, index metacarpal screw, hamate screw, CoCr cap). Implanted with bone cement by orthopedic surgeons in clinical/surgical settings. Restores joint function; provides mechanical stability for patients with degenerative or inflammatory wrist conditions.

Clinical Evidence

No clinical testing was performed. Substantial equivalence supported by non-clinical bench testing, including axial compression, construct moment bend fatigue, taper disassembly, constraint, assembly torsion, screw mechanical testing, and cadaveric evaluation.

Technological Characteristics

Materials: Cobalt-Chromium (CoCr) alloy and Ultra-High Molecular Weight Polyethylene (UHMWPE). Design: Semi-constrained, modular, cemented wrist prosthesis. Components: Radial stem, bearing surface, tray, baseplate, metacarpal/hamate screws, cap. Connectivity: N/A (mechanical implant).

Indications for Use

Indicated for patients with wrist joint disability due to pain, deformity, or limited motion from non-inflammatory degenerative disease (osteoarthritis, post-traumatic arthritis, Kienbock's disease), SLAC, rheumatoid arthritis, or failed prior treatments.

Regulatory Classification

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).

Predicate Devices

Maestro Total Wrist (K042032)
Freedom Wrist Arthroplasty System (K132250)
Remotion Total Wrist (K021859)

Related Devices

K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System · Arthrosurface, Inc. · Oct 15, 2020
K132250 — INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM · Integra LifeSciences Corporation · Mar 24, 2014
K233574 — Total Wrist Arthroplasty System (TWA) · Skeletal Dynamics · Jul 3, 2024
K021859 — WRIST IMPLANT · Avanta Orthopaedics, Inc. · Dec 2, 2002
K141920 — Wrist Hemiarthroplasty System · Arthrosurface, Inc. · Dec 23, 2014

Submission Summary (Full Text)

{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: 1. Non-inflammatory degenerative wrist disease of the radiocarpal joint including osteoarthritis, post-traumatic arthritis, and Kienbock's disease 2. Revision where other devices or treatments have failed - 3. Scapholunate Advanced Collapse (SLAC) 4. 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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: 1) Non-inflammatory degenerative wrist disease of the radiocarpal joint including osteoarthritis, post-traumatic arthritis, and Kienbock's disease 2) Revision where other devices or treatments have failed 3) Scapholunate Advanced Collapse (SLAC) 4) 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. | {4}------------------------------------------------