(28 days)
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Not Found
No
The summary describes a physical implant for joint replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
This device is an implantable prosthetic used to replace the distal radioulnar joint for conditions like arthritis or fractures, which falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is an implant for replacing the distal radioulnar joint, not a tool for diagnosing medical conditions. Its purpose is treatment through replacement, not diagnosis.
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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is an implant intended for the replacement of the distal radioulnar joint and distal ulnar head. This is a surgical implant, not a device used for testing biological samples.
- Lack of IVD Characteristics: The information does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic procedures performed outside the body.
Therefore, 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, 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
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radioulnar joint, wrist joint, distal ulnar head, ulnar head or neck
Indicated Patient Age Range
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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.
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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).
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§ 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
K072839 Pg 1 + 3
510 (k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
OCT 2 4 2008
| Prepared: | September 24, 2008 |
|---|---|
| Applicant: | Aptis Medical, LLC |
| 3602 Glenview Ave | |
| Glenview, KY 40025 | |
| Telephone | 502-523-6738 |
| Fax | 502-425-7422 |
| 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 |
| Original Predicate Device: | Distal Radio-Ulnar Joint Implant |
| Registration Number: | 3004521401 |
| 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 .
- Primary replacement after fracture of the ulnar head or neck. .
- Revision following failed ulnar head arthroplasty. .
1
K050349 pg 2 et?
Comparison to the Original Predicate Device:
The legally marketed predicate device to which this device is substantially equivalent is the same device, the Aptis Medical Distal Radio-Ulnar Joint Implant
Regulatory Class: II 87 KXE Product Code:
Comparison of original Aptis Medical Distal Radioulnar Joint to the new configuration the additional stem lengths and diameters.
Comparison of current Aptis Medical Distal Radioulnar Joint to the modified device.
| Item | Current Aptis Product | Proposed Modifications |
|---|---|---|
| Product Name | Distal Radioulnar Joint Implant | Distal Radioulnar 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 |
| Sizes | 2 sizes, 20, 30, body | |
| 25 size stems | 2 sizes, 20, 30, body | |
| 25 size 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. | 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. |
2
iK052834 ff 3 of 3
Similarities of the Aptis Medical DRUJ and the slightly modified Aptis Medical DRUJ include;
Both devices are intended for single use only; both devices are intended for surgical implantation longer than 30 days; both devices are placed into the intramedullary canal of the distal ulna; both devices are made of the same industry standard materials. No new materials are introduced in either product; both devices are comparably sized; both devices have the identical indications for use.
Summary:
The device and the predicate device have the same design characteristics and intended use. The new device is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing health, human services, and well-being. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aptis Medical, LLC % Mr. Bryan Babb 3602 Glenview Avenue Glenview, Kentucky 40025
OCT 2 4 2008
Re: K082839
Trade/Device Name: Distal Radio-Ulnar Joint Implant Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: II Product Code: KXE Dated: September 24, 2008 Received: September 26, 2008
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.
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.
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
4
Page 2 – Mr. Bryan Babb
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark W. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
Page 1 of 1
510 (k) Number (If Known): K 082839 Device Name: Distal Radio Ulnar Head 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 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. ●
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
[signature]
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
082839
510(k) Number