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.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- 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
Recent devices under product code MBH
view all- K253728 — EVOLUTION® AM BIOFOAM® Tibial System
- K251840 — Zimmer® Persona® Personalized Knee System
- K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
- K253328 — GMK 3D Metal Tibial Tray Extension
- K253637 — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
More clearances from Smith & Nephew, Inc.
view all- K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981) +1 more
- DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
- K254084 — AETOS Shoulder System - CONCELOC Glenoids
- K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0
- K252129 — AETOS Shoulder System Stemless Humeral Prosthesis
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.