(88 days)
No
The document describes a mechanical implant for radial head replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is indicated for replacement of the radial head due to degenerative or post-traumatic disabilities, fracture, symptomatic sequelae after radial head resection, and revision following failed radial head arthroplasty, all of which aim to treat existing conditions or injuries.
No
The device is a system for replacing the radial head, which is a treatment for degenerative or post-traumatic disabilities, fractures, or failed arthroplasties. It is designed to restore anatomical function rather than diagnose conditions.
No
The device description clearly states it includes "modular heads and stems with accessories" which are physical components, not software.
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 Acumed Anatomic Radial Head System is a surgical implant designed to replace a part of the radius bone. It is used inside the body.
- Intended Use: The intended use is to replace the radial head for various conditions affecting the joint. This is a therapeutic intervention, not a diagnostic test.
The information provided clearly describes a surgical implant used for treatment, not a device used for testing samples from the body.
N/A
Intended Use / Indications for Use
The Acumed Anatomic Radial Head System is indicated for use in:
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, l . crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation, resistance to conservative treatment.
-
- Primary replacement after fracture of the radial head.
-
- Symptomatic sequelae after radial head resection.
-
- Revision following failed radial head arthroplasty
Product codes
KWI
Device Description
The Acumed Anatomic Radial Head System includes modular heads and stems with accessories to anatomically replace the proximal potion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitulum of the distal humerus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial head, radio-humeral joint, proximal radio-ulnar joint, ulna, distal humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.
Description of the test set, sample size, data source, and annotation protocol
An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An assessment of performance data is not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.
0
K 041858
5885 N.W. Cornelius Pass Road, Hillsboro, Oregon 97124-9432
Tel (503) 627-9957
510(k) Summary
This sunmary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Information: Acumed LLC |
|---|
| 5885 N.W. Cornelius Pass Road |
| Hillsboro, OR 97124-9432 |
| USA |
| Phone: (503) 627-9957 |
| FAX: (503) 716-1001 |
| Contact: Ed Boehmer, Regulatory & Documentation Supervisor |
| Classification Name: | Prosthesis, Elbow, Hemi-, Radial, Polymer |
|---|---|
| Common Name: | Elbow Hemi-, Prosthesis |
| Proprietary Name: | Acumed Anatomic Radial Head System |
| Proposed Regulatory Class: | Class II, 21 CFR 888.3170 |
| Device Product Code: | KWI |
| Legally Marketed Equivalent Device(s): | Avanta Radial Head Implant K002644 |
| Wright Medical Inc. Modular Radial Head K991915 |
Device Description: The Acumed Anatomic Radial Head System includes modular heads and stems with accessories to anatomically replace the proximal potion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitulum of the distal humerus.
Intended Use: The Acumed Anatomic Radial Head System is indicated for use in:
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, l . crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation, resistance to conservative treatment.
-
- Primary replacement after fracture of the radial head.
-
- Symptomatic sequelae after radial head resection.
-
- Revision following failed radial head arthroplasty
These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.
Technological Characteristics: The Acumed Anatomic Radial Head System uses an elliptically shaped, highly polished cobalt alloy head (ASTM F1537) with a titanium alloy stem (ASTM F136). Both cobalt alloy and titanium alloy have been successfully used in numerous implant prostheses. There are no technological characteristics that raise new issues of safety or effectiveness.
An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.
Based upon the similarities of the Acumed Anatomic Radial Head System and the predicate devices studied, the safety and effectiveness of the Acumed Anatomic Radial Head System is substantially equivalent to the predicate devices referenced.
Acumed LLC Page 51
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 - 2004
Mr. Ed Boehmer Regulatory and Documentation Supervisor Acumed, LLC 5885 N.W. Cornelius Pass Road Hillsboro, Oregon 97124-9432
Re: K041858
Trade/Device Name: Acumed Anatomic Radial Head System Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: July 8, 2004 Received: July 9, 2004
Dear Mr. Boehmer:
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.
2
Page 2 – Mr. Ed Boehmer
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 (301) 594-4659. 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,
Sincerely yours,
Mark A. Millerson
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
3
1 1 Page of
| 510(k) Number (if known): | K041858 |
|---|---|
| --------------------------- | --------- |
Acumed Anatomic Radial Head System Device Name: __
Indications For Use:
The Acumed Anatomic Radial Head System and accessories are designed specifically for:
-
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation, resistance to conservative treatment.
-
- Primary replacement after fracture of the radial head.
-
- Symptomatic sequelae after radial head resection.
-
- Revision following failed radial head arthroplasty
Prescription Use
(Part 21 CFR 801 Subpart D) X
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Millner
I Restorative. Division of Ge and Neurological De
510(k) Number K041858