LANDMARK Total Knee System— 510(k) K261462
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K261462 for LANDMARK Total Knee System, Substantially Equivalent on 2026-09-08. Applicant: Smith & Nephew, Inc.. Device class: 2.
Summary
Smith & Nephew's LANDMARK Total Knee System is filed under MBH, semi-constrained, uncemented, porous-coated patellofemorotibial knee prostheses of polymer/metal/polymer construction. The record doesn't list the system's components.
Class II, 21 CFR 888.3565. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Smith & Nephew filed from Memphis, Tennessee. Review took 127 calendar days, May 4 to September 8, 2026.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Product code MBH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3565
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
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Adverse events under product code MBH
product code MBH- Injury
- 6,545
- Malfunction
- 2,023
- Total
- 8,568
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.