(30 days)
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Not Found
No
The 510(k) summary describes a mechanical implant for joint replacement and makes no mention of AI or ML technology in its intended use, device description, or performance studies.
Yes
The device is intended for the replacement of a joint to address conditions such as arthritis, pain, and instability, which are all therapeutic interventions for medical conditions.
No
The provided text describes a medical implant intended for surgical replacement of a joint, not for diagnosing diseases or conditions.
No
The device description explicitly states it includes "various sizes of implants and surgical instruments," indicating it is a physical implant and associated hardware, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant intended for the physical replacement of a joint in the body. It is a physical device implanted during surgery.
- Intended Use: The intended use clearly states it's for "replacement of the distal radioulnar joint following ulnar head resection arthroplasty." This is a surgical procedure, not a diagnostic test performed on a sample.
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:
Placement 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)
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
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Input Imaging Modality
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Anatomical Site
distal radioulnar joint, wrist joint, ulnar head, distal ulna
Indicated Patient Age Range
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Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
K053119 p1/3
510 (k) Summary
2005 DEC 7
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
| Prepared: | October 27, 2005 |
|---|---|
| Applicant: | Aptis Medical, LLC |
| 5 River Hill Road | |
| Louisville, KY 40207 | |
| Telephone | 502-899-3974 |
| Fax | 502-897-9007 |
Device Name: Device Trade Name: Device Classification: Reviewing Panel: Regulation Number Product Code: Original Predicate Device: Registration Number: Owner Operator Number:
Wrist joint ulnar (hemi-wrist) prosthesis Distal Radio-Ulnar Joint Implant Class II Orthopedic 888.3810 87 KXE Distal Radio-Ulnar Joint Implant 3004521401 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
1
K053119 p2/3
- Failed ulnar head resection; eg. Darrach resection .
- Primary replacement after fracture of the ulnar head or neck. .
- Revision following failed ulnar head arthroplasty. .
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
II Regulatory Class: 87 KXE Product Code:
Comparison of original Aptis Medical Distal Radioulnar Joint to the new configuration the additional stem lengths and diameters.
| Item | Original Aptis Product | Proposed additional size |
|---|---|---|
| Product Name | Distal Radioulnar Joint | Distal Radioulnar Joint |
| Implant | Implant | |
| Use | Single use | Single use |
| Fixation | stem in intramedulary canal, | stem in intramedulary canal, |
| screw fixation to the distal | screw fixation to the distal | |
| radius | radius | |
| Constraint | Semi constrained | Semi constrained |
| Material | Co-Cr, UHMWPe, CPTi | Co-Cr, UHMWPe, CPTi |
| Sizes | 2 sizes, 20, 30 body and | 2 sizes, 20, 30, body |
| stem | 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: | 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: | 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 | 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 | 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 | Failed ulnar head resection; eg. | |
| Darrach resection | ||
| Primary replacement after fracture | ||
| of the ulnar head or neck. | Primary replacement after fracture | |
| of the ulnar head or neck. |
2
K053119 p³/₃
Revision following failed ulnar head arthroplasty.
Revision following failed ulnar head arthroplasty.
Similarities of the Aptis Medical DRUJ and the Aptis Medical DRUJ additional length and diameter stems 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 and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the shape of a bird. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
DEC 7 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bryan Babb Aptis Medical, LLC. 5 River Hill Road Louisville, Kentucky 40207
Re: K053119
Trade/Device Name: Distal Radio-Ulnar Joint Implant (DRUJ) Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: II Product Code: KXE Dated: October 27, 2005 Received: November 7, 2005
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 Cossmetic 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 elcctronic product radiation control provisions (Scctions 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Bryan Babb
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oogh manieting your and equivalence of your device to a legally premarket notheation: "The PDA maing of castion 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 If you desire specific at not 10-1 at (240) 276-0120. Also, please note the regulation entitled, Contact the Oriece of Commarket notification" (21CFR Part 807.97). You may obtain Misoranung Uy releveloe to premanton on your responsibilities under the Act from the Division of Small other general information of your copsumer Assistance at its toll-free number (800) 638-2041 or 1011) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): 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)
Mark A. Milliken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number