Driver, Prosthesis
A prosthesis driver is a handheld orthopedic instrument used to apply controlled force to seat or advance a prosthetic implant component into its intended position in bone during joint replacement surgery. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HWR falls under the Orthopedic medical specialty.
Research product code HWR in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HWR
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K915776 | KNEE PROSTHESIS DRIVER | Jun 11, 1992 | Substantially Equivalent | Kim-Med, Inc. |
| K875054 | ACROMED ADS BONE NAIL DRIVER | Jan 28, 1988 | Substantially Equivalent | Buckman Co., Inc. |
| K870848 | SCHULTZ METACARPAL COMPONENT DRIVER | Mar 13, 1987 | Substantially Equivalent | Warsaw Orthopedic, Inc. |
| K870847 | SCHULTZ PHALANGEAL COMPONENT DRIVER | Mar 13, 1987 | Substantially Equivalent | Warsaw Orthopedic, Inc. |
FEI Numbers
This FDA classification entry is associated with 180 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 180 registration numbers. Click on an entry to view related FDA registrations.