(30 days)
The reference device(s) K/DEN number are: Not Found
No
The document describes a mechanical implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is an implantable medical device used to replace the radial head, thereby treating conditions like degenerative disabilities, post-traumatic disabilities, and fractures. Its purpose is to alleviate pain, restore motion, and correct joint destruction, which are all therapeutic outcomes.
No
Explanation: This device is an implantable medical device (Modular Radial Head Implant System) used for replacement or revision of the radial head. Its purpose is therapeutic, not diagnostic. While its use can be considered for conditions visible on x-ray, the device itself does not perform diagnostics.
No
The device description clearly states it is a "Modular Radial Head Implant System," which is a physical implant, 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 describes a surgical implant for replacing the radial head in the human body. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "Modular Radial Head Implant System," which is a type of prosthetic device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device's purpose is to surgically replace a damaged anatomical structure.
N/A
Intended Use / Indications for Use
Use of the Modular Radial Head Implant may be considered for :
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- a. joint destruction and/or subluxation visible on x-ray; and/or
- b. 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 EVOLVE® Modular Radial Head Implant System is being extended to include additional size stems and heads. The design features of these additional sizes are identical to the previously submitted and cleared stems and heads under 510(k); K991915- EVOLVE® Modular Radial Head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radio-humeral and/or proximal radio-ulnar 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)
Reference Device(s)
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
§ 888.3170 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
APR 1 9 2006
Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in large, bold, sans-serif font. Below the word is a graphic of three arrows pointing to the right. Underneath the arrows is the alphanumeric code "K060731" in a handwritten style font.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLVE® Modular Radial Head.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | March 17, 2006 |
| Contact Person: | Wesley L. Reed |
| Regulatory Affairs Specialist II | |
| Proprietary Name: | EVOLVE® Modular Radial Head |
| Common Name: | Modular Radial Head |
| Classification Name and Reference: | 21 CFR 888.3170 Elbow joint radial (hemi elbow) polymer prosthesis – Class II |
| Device Product Code and Panel Code: | Orthpedics/87/KWI |
DEVICE INFORMATION
A. INTENDED USE
Use of the Modular Radial Head Implant may be considered for :
- . Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- a. joint destruction and/or subluxation visible on x-ray; and/or
- b. resistance to conservative treatment.
- Primary replacement after fracture of the radial head. .
- Symptomatic sequelae after radial head resection. .
- Revision following failed radial head arthroplasty. .
B. DEVICE DESCRIPTION
The EVOLVE® Modular Radial Head Implant System is being extended to include additional size stems and heads. The design features of these additional sizes are identical to the previously submitted and cleared stems and heads under 510(k); K991915- EVOLVE® Modular Radial Head.
headquarters
Wright Medical Technology, Inc.
5677 Airline Road
Arlington, TN 38002
901.867.9971 pho
international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy
905.826.1600 Canada
011.81.3.3538.0474 Japan
011.33.1.45.13.24.40 France 011.44.1483.721.404 UK
1.49.4161.745130 Germany
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C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, type of interface, operating principles, shelf life, and design features of the EVOLVE® Radial Head Implant are substantially equivalent to the head component covered under the EVOLVE® Modular Radial Head 510(k): K991915. Additionally, the safety and effectiveness of the EVOLVE® Radial Head Implant is adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2006
Wright Medical Technologies, Inc. c/o Mr. Wesley L. Reed Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Re: K060731
Trade/Device Name: EVOLVE Modular Radial Head Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: Class II Product Code: KWI Dated: March : 7, 2006 Received: March 20, 2006
Dear Mr. Reed:
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 CTR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set
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Page 2 - Mr. Wesley L. Reed
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 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/industry/support/index.html.
Sincerely yours,
Herbert Leonard
Mark N. Melkerson 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
K060731 510(k) Number (if known):
Device Name: EVOLVE® Modular Radial Head
Indications For Use:
Use of the Modular Radial Head Implant may be considered for :
- Replacement of the radial head for degenerative or post-traumatic disabilities . presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- a. joint destruction and/or subluxation visible on x-ray; and/or
- b. 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) 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)
Huler Lemusica
1 of 1
(Division SELECT == C == 1 Division of General, Restorativ. and Neurological Devices
510(k) Number K100731