Howmedica Kinematic Ii Tibial Wedge
510(k) K842367
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842367 | Date17 Aug 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HRY
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3530
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Howmedica Kinematic Ii Tibial Wedge is a prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer device. It is classified as a Class 2 device. The device is used in orthopedic applications.
The device is supplied by Howmedica Corp and has been cleared under FDA 510K number K842367. It is intended for use in the US and has a product code of HRY. The device is regulated under regulation number 888.3530 and has been assigned a device class of 2.
Other devices from Howmedica Corp.
Questions
AI-generated answers, 25 Sep 2026
What is the Howmedica Kinematic II Tibial Wedge used for?
The Howmedica Kinematic II Tibial Wedge is used in orthopedic applications, specifically as a knee prosthesis.
What type of device is the Howmedica Kinematic II Tibial Wedge?
The Howmedica Kinematic II Tibial Wedge is a semi-constrained, cemented, metal/polymer device.
Is the Howmedica Kinematic II Tibial Wedge supplied sterile?
The device data does not specify if the Howmedica Kinematic II Tibial Wedge is supplied sterile, it is recommended to check the packaging or manufacturer's instructions.
What is the regulatory classification of the Howmedica Kinematic II Tibial Wedge?
The Howmedica Kinematic II Tibial Wedge is classified as a Class 2 device and is regulated under regulation number 888.3530.