(203 days)
Not Found
No
The document describes a mechanical implant for joint replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
It is intended for replacement of the distal radioulnar joint due to various medical conditions, aiming to alleviate pain and restore function, which are therapeutic purposes.
No
The device is an implant for joint replacement, not a diagnostic tool for identifying or characterizing a medical condition.
No
The device description explicitly states it is an implant system made of materials like Co-Cr, UHMWPe, and CPTi, and includes surgical instruments, indicating it is a physical medical device, not software.
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 an implant for the replacement of the distal radioulnar joint. This is a surgical procedure performed in vivo (within the body).
- Device Description: The description details a physical implant made of materials like Co-Cr, UHMWPe, and CPTi, designed to be surgically placed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve reagents, analyzers, or test kits used in vitro (outside the body).
Therefore, the Aptis Medical Distal Radio Ulnar Joint implant is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aptis Medical Distal Radio Ulnar Joint implant is intended for replacement of the distal radioulnar 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 radioulnar 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.
Product codes
KXE
Device Description
The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes various sizes of implants (10-30) 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
distal radioulnar joint, distal ulnar head, wrist joint, ulna, distal radius
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Mechanical testing was performed on the subject device including; static compression, static tension, and dynamic compression tests. These tests demonstrate that the device withstood comparable loads under similar test conditions. No clinical data was submitted to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized symbol consisting of three abstract human profiles facing right, with flowing lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2015
Aptis Medical, LLC Mr. Bryan Babb Quality Assurance Manager 3602 Glenview Avenue Glenview, Kentucky 40025
Re: K142569
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: February 26, 2015 Received: March 2, 2015
Dear Mr. Babb:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 – Mr. Bryan Babb
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142569
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 radioulnar 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 radioulnar 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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"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
3. 510(k) Summary
Summary of 510(k) safety and effectiveness information upon which the substantial equivalence determination is based:
- I. Submitter Date Prepared: April 3, 2015 Device Submitter: Aptis Medical, LLC 3602 Glenview Ave Glenview, KY 40025 Phone: (502)-523-6738 Contact Person: Bryan Babb II. Device Aptis Medical Distal Radio Ulnar Joint Implant Device Name: Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: II Product Code: KXE III. Predicate Device Predicate Device: Aptis Medical: K040497 Distal Radio Ulnar Joint Implant K053119 Distal Radio Ulnar Joint Implant K082839 Distal Radio Ulnar Joint Implant
- IV. Device Description
The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes various sizes of implants (10-30) 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 radioulnar 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
4
- Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar 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 very similar to the predicate device. The 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.
| Item | Aptis Medical | Aptis Medical Predicate |
|---|---|---|
| Product Name | Aptis Medical Distal Radio Ulnar | |
| Joint Implant | Aptis Medical Distal Radio Ulnar | |
| Joint Implant | ||
| Use | Single use | Single use |
| Fixation | Stem in intramedullary canal, | |
| screw fixation to the distal radius | Stem in intramedullary canal, | |
| screw fixation to the distal radius | ||
| Constraint | Semi-constrained | Semi-constrained |
| Material | Co-Cr, UHMWPe, CPTi | Co-Cr, UHMWPe, CPTi |
| Available Sizes | 10, 20, 30 | |
| Various stem sizes ranging in | ||
| diameter from 4 to 6 mm | 20, 30 | |
| Various stem sizes ranging in | ||
| diameter from 4 to 6 mm | ||
| Indications for | ||
| use | The Aptis Medical Distal Radio | |
| Ulnar Joint Implant is intended for | ||
| replacement of the distal | ||
| radioulnar 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 radioulnar joint
● Failed ulnar head resection; | The Aptis Medical Distal Radio
Ulnar Head Implant is intended
for replacement of the distal
radioulnar 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 radioulnar joint
● Failed ulnar head resection; |
5
| 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. | 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. |
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
VII. Performance Data
Mechanical testing was performed on the subject device including; static compression, static tension, and dynamic compression tests. These tests demonstrate that the device withstood comparable loads under similar test conditions. No clinical data was submitted to support substantial equivalence.
Conclusions VIII.
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. Mechanical test data demonstrates that the Aptis Medical Distal Radio Ulnar Joint Implant is as safe and effective as the predicate device. Thus the Aptis Medical Distal Radio Ulnar Joint Implant is substantially equivalent to the predicate.