(88 days)
KWI
Not Found
No
The summary describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, a "Modular Radial Head Implant," is used to replace damaged or painful joints for various medical conditions, indicating a therapeutic purpose.
No
This device is a radial head implant used for joint replacement, not for diagnosing conditions. Its description focuses on materials and design for implantation, and its use is indicated for treating existing conditions.
No
The device description explicitly states it is manufactured from Cobalt Chrome and is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant used to replace the radial head in the elbow joint. It is a physical device implanted into the body to restore function and alleviate symptoms.
- No mention of biological samples or testing: The description focuses on the physical characteristics of the implant and its surgical application. There is no mention of analyzing biological samples or performing any diagnostic tests on them.
- Input Imaging Modality: The mention of "x-ray" as an input imaging modality further supports that this is a device used in conjunction with medical imaging for surgical planning and assessment, not an in vitro diagnostic test.
Therefore, based on the provided information, the Modular Radial Head Implant is a medical device used for surgical intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Use of the Modular Radial Head Implants 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:
- joint destruction and/or subluxation visible on x-ray; and/or
- 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 Modular Radial Head is manufactured from Cobalt Chrome (ASTM F 1537) . The stem is designed to be a two-piece modular design that is assembled at the time of implantation. The proximal portion of the head is concave and has rounded contours. The head and stem are available in standard sizes and +2 and +4 configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
radial head, radio-humeral joint, proximal radio-ulnar joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Metallic Radial Head Implant
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
SEP 13 1999
Attachment 2
Summary
510(k) Summary
Company: Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002
Date: June 7, 1999 Trade Name: Modular Radial Head Common Name: Radial Head Prosthesis Predicate Device: Metallic Radial Head Implant
Description/Intended Use:
The Modular Radial Head is manufactured from Cobalt Chrome (ASTM F 1537) . The stem is designed to be a two-piece modular design that is assembled at the time of implantation. The proximal portion of the head is concave and has rounded contours. The head and stem are available in standard sizes and +2 and +4 configurations.
Use of the Modular Radial Head Implants 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. .
The Modular Radial Head was declared substantially equivalent to the predicate devices. Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents.
1
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 1999
Ms. Lynne Witkowski Regulatory Affairs Associate Wright Medical Technology Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K991915 Trade Name: Modular Radial Head Regulatory Class: II Product Code: KWI Dated: June 4, 1999 Received: June 7, 1999
Dear Ms. Witkowski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
2
Page 2 - Ms. Lynne Witkowski
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colin M. Witter, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| Attachment 3 | Indications for Use Statement |
|---|---|
| 510(k) Number | |
| (if known) | K991915 |
| Device Name | Modular Radial Head |
| Indications for Use | Intended Use |
| Use of the Modular Radial Head Implants 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: joint destruction and/or subluxation visible on x-ray; and/orresistance to conservative treatment.Primary replacement after fracture of the radial head.Symptomatic sequelae after radial head resection.Revision following failed radial head arthroplasty. |
Revision following failed radial head arthroplasty. .
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF
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Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use (per 21 CFR 801.109)
OR
Over-The Counter Use
P cóll
(Division Sigh-Off) Division of General Restorative Devices 510(k) Number -