(56 days)
The Aptis Medical Distal Radio Ulnar Joint Implant is intended for replacement of the distal radio ulnar joint following ulnar head resection arthroplasty:
Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:
- · Pain and weakness of the wrist joint not improved by non-operative treatment
- · Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radio ulnar joint
- · Failed ulnar head resection; e.g. Darrach resection
- · Primary replacement after fracture of the ulnar head or neck.
- · Revision following failed ulnar head arthroplasty.
This prosthesis is intended for single use only.
The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes various sizes of implants (10-30 and multiple stems) to accommodate the anatomy of the distal ulna. The implants are made from the same materials as the predicate including: Co-Cr, UHMWPe and CPTi. Surgical instruments are also available to facilitate surgical placement of the implant. The implant allows for the replacement of the distal ulnar head.
The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.
The document is a 510(k) premarket notification summary for the Aptis Medical Distal Radio Ulnar Joint Implant. The key information provided relates to its substantial equivalence to a predicate device, regulatory classifications, and indications for use.
Specifically, Section VII, "Performance Data," states: "Evaluation in the MRI environment of the subject device was performed through computational modeling and simulation of radiofrequency induced heating. No clinical data was submitted to support substantial equivalence." This explicitly indicates that a study demonstrating device performance against acceptance criteria, particularly clinical performance, was not conducted or submitted for this specific premarket notification.
Therefore, I cannot extract the requested information from the provided text.
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Aptis Medical, LLC % Louise Focht President ENMED Intemtional, Inc PO Box 249 Del Mar, California 92014 May 3, 2019
Re: K190599
Trade/Device Name: Aptis Medical Distal Radio Ulnar Joint Implant Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist Joint Ulnar (Hemi-Wrist) Polymer Prosthesis Regulatory Class: Class II Product Code: KXE Dated: March 6, 2019 Received: March 8, 2019
Dear Louise Focht:
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
FOR CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 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) K190599
Device Name
Aptis Medical Distal Radio Ulnar Joint Implant
Indications for Use (Describe)
The Aptis Medical Distal Radio Ulnar Joint Implant is intended for replacement of the distal radio ulnar joint following ulnar head resection arthroplasty:
Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:
- · Pain and weakness of the wrist joint not improved by non-operative treatment
- · Instability of the ulnar head with radiographic evidence of dislocation or
erosive changes of the distal radio ulnar joint
- · Failed ulnar head resection; e.g. Darrach resection
- · Primary replacement after fracture of the ulnar head or neck.
- · Revision following failed ulnar head arthroplasty.
This prosthesis is intended for single use only.
| 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) |
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K190299 Page 1 of 2
510(k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
- I. Submitter
| Date Prepared: | April 30, 2019 |
|---|---|
| Device Submitter: | Aptis Medical, LLC3602 Glenview Ave.Glenview, KY 40025Establishment Registration Number:3004521401 |
| Phone: | (502)-523-6738 |
| Contact Person: | Bryan Babb |
II. Device
| Proprietary Name: | Aptis Medical Distal Radio Ulnar Joint Implant |
|---|---|
| Common Name: | DRUJ |
| Classification Name: | Wrist joint ulnar (hemi-wrist) prosthesis |
| Regulatory Class: | 21 CFR 888.3810, Class II |
| Product Code: | 87 KXE |
III. Predicate Device
| Predicate Device: | Aptis Medical Distal Radio Ulnar Joint ImplantPrimary predicate: K142569Additional predicates: K082839, K040497 |
|---|---|
| ------------------- | ------------------------------------------------------------------------------------------------------------------------- |
IV. Device Description
The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes various sizes of implants (10-30 and multiple stems) to accommodate the anatomy of the distal ulna. The implants are made from the same materials as the predicate including: Co-Cr, UHMWPe and CPTi. Surgical instruments are also available to facilitate surgical placement of the implant. The implant allows for the replacement of the distal ulnar head.
V. Indications for Use
The Aptis Medical Distal Radio Ulnar Joint Implant is intended for replacement of the distal radio ulnar joint following ulnar head resection arthroplasty:
- · Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:
- · Pain and weakness of the wrist joint not improved by non-operative treatment
- Instability of the ulnar head with radiographic evidence of dislocation or
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erosive changes of the distal radio ulnar joint
- · Failed ulnar head resection; e.g. Darrach resection
- · Primary replacement after fracture of the ulnar head or neck.
- · Revision following failed ulnar head arthroplasty.
This prosthesis is intended for single use only.
-
VI. Comparison of technological characteristics with the predicate device
The technological characteristics of the Aptis Medical Distal Radio Ulnar Joint Implant are the same as the Aptis Medical predicate device consists of a plate of various sizes which is fixed to the radius and a stem of various sizes which is fixed to the ulna. The principal of operation of the device is the same as that of the predicate. -
VII. Performance Data
Evaluation in the MRI environment of the subject device was performed through computational modeling and simulation of radiofrequency induced heating. No clinical data was submitted to support substantial equivalence.
VIII. Conclusions
The Aptis Medical Distal Radio Ulnar Joint Implant when compared to the predicate has the same indications for use, technological characteristics, and principals of operation as the predicate device. The Aptis Medical Distal Radio Ulnar Joint Implant is as safe and effective as the predicate device. This submission does not raise any new types of questions of safety or effectiveness and thus is substantially equivalent to the predicate device.
§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
(a)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.(b)
Classification. Class II.