(188 days)
No
The document describes a physical implant device and its materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a radial head implant used to replace a damaged joint, which is a therapeutic intervention aimed at restoring function and reducing pain.
No
This device is an implantable radial head replacement, not a device used to diagnose medical conditions.
No
The device description clearly describes a physical implant made of CoCr and ceramic materials, intended for surgical replacement of the radial head. This is a hardware medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this is a "Modular Radial Head Implant." This is a surgical implant designed to replace a part of the body.
- Intended Use: The intended use is for the "Replacement of the radial head" and "Primary replacement after fracture of the radial head," among other surgical procedures. This involves direct surgical intervention on the patient's body, not the analysis of in vitro specimens.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
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® Ceramic Radial Head Implant is identical to the head component previously submitted and cleared under 510(k): K991915- EVOLVE® Modular Radial Head. The only difference between the two devices is the type of materials used to manufacture the head components. The EVOLVE® Modular Radial Head system is approved with a CoCr head component, and a CoCr stem component. Wright Medical Technology is now adding a ceramic head component for use with the CoCr stem component previously cleared under the EVOLVE® Modular Radial Head (510(k): K991915).
The design features for both EVOLVE® radial head components are as follows:
- The proximal portion of the radial head will have a concave design to provide . stability to the bearing surface and closely approximate the natural anatomy of the radial head and humeral-capitellum articulating surface.
- The sides of the head are designed with a radius of curvature that articulates with the . proximal radial-ulnar joint and closely approximates the natural anatomy.
- The heads are interchangeable, since the interface has the same dimensions ● throughout the system.
- Heads are available in 2.0mm increments, ranging from 20.0mm to 28.0mm in . diameter.
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)
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.
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AUG 1 2 2003
K030384 Pa
Image /page/0/Picture/2 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" formed by three thick, angled lines, followed by the text "WRIGHT" stacked above "MEDICAL" and "TECHNOLOGY". The text is in a simple, sans-serif font, and the entire logo is in black and white.
A Wright Medical Group Company 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® Ceramic Radial Head Implant.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | February 3, 2003 |
| Contact Person: | Jeanine H. Redden |
| Regulatory Affairs Associate | |
| Proprietary Name: | EVOLVE® Ceramic Radial Head Implant |
| Common Name: | RADIAL HEAD PROSTHESIS |
| Classification Name and Reference: | 21 CFR 888.3170 Prosthesis, Elbow, Hemi-, Radial, |
| Polymer - Class II | |
| Device Product Code and Panel Code: | Orthopedics/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. ●
C. DEVICE DESCRIPTION
The EVOLVE® Ceramic Radial Head Implant is identical to the head component previously submitted and cleared under 510(k): K991915- EVOLVE® Modular Radial Head. The only difference between the two devices is the type of materials used to
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K010384 P090 *42
Special 510(k) EVOLVE® Ceramic Radial Head Implant 510(K) SUMMARY Page 2 of 2
manufacture the head components. The EVOLVE® Modular Radial Head system is approved with a CoCr head component, and a CoCr stem component. Wright Medical Technology is now adding a ceramic head component for use with the CoCr stem component previously cleared under the EVOLVE® Modular Radial Head (510(k): K991915).
The design features for both EVOLVE® radial head components are as follows:
- The proximal portion of the radial head will have a concave design to provide . stability to the bearing surface and closely approximate the natural anatomy of the radial head and humeral-capitellum articulating surface.
- The sides of the head are designed with a radius of curvature that articulates with the . proximal radial-ulnar joint and closely approximates the natural anatomy.
- The heads are interchangeable, since the interface has the same dimensions ● throughout the system.
- Heads are available in 2.0mm increments, ranging from 20.0mm to 28.0mm in . diameter.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, type of interface, operating principles, shelf life, and design features of the EVOLVE® Ceramic Radial Head Implant are substantially equivalent to the head component covered under the EVOLVE® Modular Radial Head (510(k): K991915). The sterilization process and material used to manufacture the EVOLVE® Ceramic Radial Head Implant is substantially equivalent to the ORTHOSPHERE® Ceramic Spherical CMC Implant - 510(k): K960659. Additionally, the safety and effectiveness of the EVOLVE® Ceramic Radial Head Implant is adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification.
Image /page/1/Picture/10 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, serif typeface. Below the word "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.
Image /page/1/Picture/11 description: The image shows a black and white photograph of a partial view of the Earth from space. The Earth is partially illuminated by the sun, with the sunlit portion showing landmasses and cloud cover. The unlit portion of the Earth is dark, with only a faint glow visible along the horizon. The curvature of the Earth is clearly visible, emphasizing its spherical shape.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an emblem featuring a stylized depiction of three birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2003
Ms. Jeanine H. Redden Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002
Re: K030384
Trade/Device Name: EVOLVE® Ceramic Radial Head Implant Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: July 17, 2003 Received: July 18, 2003
Dear Ms. Redden:
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. Jeanine H. Redden
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) 594-4639. 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 may be obtained 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,
Clay Witt
Colie M. Witton, Ph.D., M.
ia 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
4
K03.384
Image /page/4/Picture/1 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other on the right. The "W" is made up of three thick, black, angled lines, and the words are in a simple, sans-serif font.
A Wright Medical Group Company
EVOLVE® Ceramic Radial Head Implant
INDICATIONS STATEMENT
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
ision Sign-Off Division of General Restorativ 510(k) Number
Over-The Counter Use No (Optional Format 1-2-96)
Prescription Use (Per21 CFR 801.199
OR
Image /page/4/Picture/18 description: The image shows the logo for Wright Medical Technology. The logo consists of a large, stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo is the text "A Wright Medical Group Company".
5 6 7 7 Airline Road Arlington, Tennessee 38002 r 901 - 8 6 7 - 9 9 7 1