(335 days)
Not Found
Not Found
No
The summary describes a physical implant and surgical instruments, with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is an implant intended to replace the distal radioulnar joint due to various medical conditions, directly treating a condition or injury.
No
Explanation: The device described is an implant intended for replacement of a joint, not for diagnosing a condition.
No
The device description explicitly states it includes "various sizes of implants and surgical instruments," indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device Description: The description clearly states this is an "ulnar head implant" intended for "replacement of the distal radioulnar joint." This is a surgical implant that is placed inside the body.
- Intended Use: The intended use describes the conditions for which the implant is used to replace a part of the body. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
Therefore, based on the provided information, the Aptis Medical Distal Radio Ulnar Head implant is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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; eg. Darrach resection
- Primary replacement after fracture of the ulnar head or neck. ●
- Revision following failed ulnar head arthroplasty. .
Product codes (comma separated list FDA assigned to the subject device)
87 KXE
Device Description
The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radioulnar joint
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
WMT Modular Ulnar Head, Wright Medical Technology, Inc.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JAN 2 6 2005
510 (k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
February 25, 2004 Prepared:
Applicant: Aptis Medical, LLC 5 River Hill Road Louisville, KY 40207
| Device Name: | Wrist joint ulnar (hemi-wrist) prosthesis |
|---|---|
| Device Trade Name: | Distal Radio-Ulnar Joint Implant |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 888.3810 |
| Product Code: | 87 KXE |
| Predicate Device: | WMT Modular Ulnar Head, Wright |
| Medical Technology, Inc. |
Owner Operator Number:
9054354
Device Description:
The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.
Indications for Use:
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; eg. Darrach resection
1
- Primary replacement after fracture of the ulnar head or neck. ●
- Revision following failed ulnar head arthroplasty. .
Comparison to Predicate Device:
The legally marketed predicate device to which this device is substantially equivalent is the Wright Medical Technologies Modular Ulnar Head Implant.
Regulatory Class: II Product Code: 87 KXE
| Item | Aptis Product | Wright Medical Technologies |
|---|---|---|
| Product Name | Distal Radioulnar Joint Implant | WMT Modular Ulnar Head Implant |
| Use | Single use | Single use |
| Fixation | stem in intramedulary canal, screw fixation to the distal radius | stem in intramedulary canal |
| Constraint | Semi constrained | non constrained |
| Material | Co-Cr, UHMWPe, CPTi | Co-Cr, Titanium Alloy, Plasma Spray |
| Sizes | 2 sizes, 1, 2 | 8 heads, 6 stems |
| Indications for use | 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; eg. Darrach resection | ||
| Primary replacement after fracture of the ulnar head or neck. | ||
| Revision following failed ulnar head arthroplasty | WMT 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; eg. Darrach resection | ||
| Primary replacement after fracture of the ulnar head or neck. | ||
| Revision following failed ulnar head arthroplasty |
Table 1. Comparison of Aptis and WMT ulnar head.
Similarities of the Aptis Medical, LLC and WMT Modular Ulnar Head Implant include:
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Both devices are: intended for single use only; intended for surgical implantation longer than 30 days; placed into the intramedullary canal of the distal ulna; made of industry standard materials; comparable in size; and have the same indications for use.
Summary:
The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 6 2005
Aptis Medical, LLC C/o Ms. Louise M. Focht P.O. Box 249 Del Mar, California 92014
Re: K040497
Trade/Device Name: Distal Radio-Ulnar Joint Implant Regulation Numbers: 21 CFR 888.3810 Regulation Names: Wrist joint ulnar (hemi-wrist) polymer prosthesis Product Code: KXE Dated: November 22, 2004 Received: November 23, 2004
Dear Ms. 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
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Page 2 – Ms. Louise M. Focht
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K040497, Device Name: Distal Radio-Ulnar Joint Implant Indications for Use:
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 radiouinar joint
- Failed ulnar head resection; eg. Darrach resection .
- Primary replacement after fracture of the ulnar head or neck. .
- Revision following failed ulnar head arthroplasty. .
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Mark A. Millhause
Division of General, Restorative, and Neurological Devices
Page of
K040497 510(k) Number_