Total Knee System (K822583)
by Richard'S Medical Equip., Inc. 2 variants
510(k) K822583
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822583 | Date4 Oct 1982 | 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- Withdrawn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
- Full name
- Total Knee System
- 510(k) Number
- FDA Product Code
- MBV
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3560
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Total Knee System is a Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, UHMWPE, Pegged, Cemented, composed of polymer/metal/polymer materials. It is designed to replace damaged knee joints, restoring function and mobility by articulating the femur, tibia, and patella with engineered surfaces. The semi-constrained design provides stability while accommodating natural movement patterns, making it suitable for total knee arthroplasty procedures.
This device is supplied as a sterile, single-use implant intended for surgical use in orthopedic settings. It is cemented into place during surgery and requires MRI safety evaluation based on its metallic and polymer components. Multiple component sizes are available to match patient anatomy, and storage follows sterile packaging protocols. Authorized under FDA 510(k) clearance (K822583) as substantially equivalent, it adheres to regulatory classification under 888.3560 for knee prostheses.