510(k) clearance
LANDMARK Total Knee System
- 510(k) number
- K261462
- Applicant
- Smith & Nephew, Inc.
- Decision date
- Sep 8, 2026
- Date received
- May 4, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MBH
- Device type
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class II
- Regulation
- 21 CFR 888.3565
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Memphis, TN, US