(239 days)
Not Found
No
The summary describes a mechanical implant and does not mention any AI or ML components or functions.
Yes
The device is described as a "Radial Head Prosthesis" intended for "replacement of the proximal end of the radius due to degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion." Its purpose is to alleviate symptoms and restore function, which aligns with the definition of a therapeutic device.
No
The device is a prosthesis intended for replacement of a joint, not for diagnosing a condition.
No
The device description explicitly states it includes "various sizes of implants," which are physical hardware components.
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 a damaged part of the radius bone. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description confirms it's an implantable prosthesis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on such analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a physical condition.
N/A
Intended Use / Indications for Use
The Radial Head Prosthesis is intended for replacement of the proximal end of the radius due to degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and/or proximal radio-ulnar joint involving joint destruction or subluxation visible on xray, resistance to conservative treatment; primary replacement after fracture of the radial head; and symptomatic sequelae after radial head resection.
Product codes (comma separated list FDA assigned to the subject device)
87KWI
Device Description
The Radial Head Prosthesis, like the predicate devices, includes various sizes of implants to accommodate the requirements of patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal end of the radius, radiohumeral 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): 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.
Avanta Orthopaedics Radial Head Implant (K982288), Swanson Titanium Radial Head Implant (K944507), Implex Radial Head Replacement System (K984290)
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.
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
510(k) Summary Radial Head Prosthesis
K 92220
| Submitter's name: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| Submitter's address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's telephone number: | 901/399-5153 |
| Contact person: | Janet Johnson Green |
| Date summary prepared (amended): | February 1, 2000 |
| Trade or proprietary device name: | Radial Head Prosthesis |
| Common or usual name: | Radial Head Implant |
| Classification name: | Title 21 CFR 888.3170 |
| Elbow joint radial (hemi-elbow) prosthesis | |
| Device Class: | Class II |
| Device Product Code and Panel Code: | 87KWI |
Panel: Orthopaedics/87
Substantially Equivalent, Legally Marketed Predicate Devices:
| Avanta Orthopaedics Radial Head Implant | Avanta Orthopaedics | (K982288) |
|---|---|---|
| Swanson Titanium Radial Head Implant | Wright Medical Technology | (K944507) |
| Implex Radial Head Replacement System | Implex Corporation | (K984290) |
Subject device description:
The Radial Head Prosthesis, like the predicate devices, includes various sizes of implants to accommodate the requirements of patient anatomy.
Subject device intended use:
The Radial Head Prosthesis is intended for replacement of the proximal end of the radius due to:
- degenerative or post-traumatic disabilities presenting pain, crepitation and decreased ● motion at the radiohumeral and/or proximal radio-ulnar joint with:
- joint destruction or subluxation visible on x-ray ●
- . resistance to conservative treatment
- . primary replacement after fracture of the radial head
- symptomatic sequelae after radial head resection ●
The Radial Head Prosthesis is for single use only.
Technolocgical Characteristics:
The Radial Head Prosthesis is similar to legally marketed devices listed above in that all of these devices are indicated for radial head replacement and are similar in technological characteristics. The Radial Head Prosthesis is manufactured from Cobalt-Chrome, ASTM F 90, ISO 5832-5.
1
Image /page/1/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 abstract symbol that resembles an eagle or bird in flight.
Public Health Service
FEB 2 5 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Janet Johnson Green Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116
Re: K992220 Trade Name: Radial Head Prosthesis Regulatory Class: II Product Code: KWI Dated: February 7, 2000 Received: February 10, 2000
Dear Ms. Green:
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 control provisions of the Act. The general control 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. Janet Johnson Green
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,
Russell Sage
رمه James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: Radial Head Prosthesis
Indications for Use:
The Radial Head Prosthesis is intended for replacement of the proximal end of the radius due to degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and/or proximal radio-ulnar joint involving joint destruction or subluxation visible on xray, resistance to conservative treatment; primary replacement after fracture of the radial head; and symptomatic sequelae after radial head resection.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Xavier Jugan
(Division Sign-Off) Division of General Re 510(k) Number
Prescription Use X (Per 21 CFR 601.109) OR
Over-The-Counter Use