SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION— 510(k) K121393

Clearance details

Applicant

Smith & Nephew, Inc.

Product code

Code MBH

Device class

Class 2

Regulation

21 CFR 888.3565

Advisory panel

Orthopedic

Date received

2012-05-09

Decision date

2012-08-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Memphis, TN, US

• K261462 — LANDMARK Total Knee System2026-09-08
• K253728 — EVOLUTION® AM BIOFOAM® Tibial System2026-08-21
• K251840 — Zimmer® Persona® Personalized Knee System2026-05-28
• K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)2026-03-09
• K253328 — GMK 3D Metal Tibial Tray Extension2026-02-26

• K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981) +1 more2026-07-09
• DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455)2026-07-06
• K254084 — AETOS Shoulder System - CONCELOC Glenoids2026-04-06
• K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 02025-10-29
• K252129 — AETOS Shoulder System Stemless Humeral Prosthesis2025-10-03

Injury

6,545

Malfunction

2,023

Total

8,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0878-2020 — LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).Class II·Ongoing·Smith & Nephew, Inc.·20191216
• Z-0200-2019 — Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.Class II·Terminated·Smith & Nephew, Inc.·20180918
• Z-2163-2018 — smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)Class II·Terminated·Smith & Nephew, Inc.·20180504
• Z-1902-2018 — smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.Class II·Terminated·Smith & Nephew, Inc.·20180409

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121393.