Fusion Taper System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K201047 ↗

FDA product code

LZO

FDA applicant

Signature Orthopaedics Pty, Ltd.

Device class

Class II

Regulation

21 CFR Part 888.3353

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

• Active-V Knee Cementless CR Femoral Component - Size 1 Narrow - Left 10-1521-0302

  Class II

  FDA 510(k) K253239 Active Cleared 23 Dec 2025 GUDID on market

• Active-V Knee Cementless CR Femoral Component - Size 1 Narrow - Right 10-1522-0322

  Class II

  FDA 510(k) K253239 Active Cleared 23 Dec 2025 GUDID on market

• Active-V Knee Cementless CR Femoral Component - Size 1 - Left 10-1521-0303

  Class II

  FDA 510(k) K253239 Active Cleared 23 Dec 2025 GUDID on market

• Active-V Knee Cementless CR Femoral Component - Size 1 - Right 10-1522-0323

  Class II

  FDA 510(k) K253239 Active Cleared 23 Dec 2025 GUDID on market

• Active-V Knee Cementless CRFemoral Component - Size 2 Narrow - Left 10-1521-0304

  Class II

  FDA 510(k) K253239 Active Cleared 23 Dec 2025 GUDID on market

• Active-V Knee Cementless CR Femoral Component - Size 2 Narrow - Right 10-1522-0324

  Class II

  FDA 510(k) K253239 Active Cleared 23 Dec 2025 GUDID on market

See all devices from Signature Orthopaedics Pty Ltd →

• What is the purpose of the Fusion Taper System?

  The Fusion Taper System is an orthopedic device designed to connect femoral stems to acetabular cups. It features a longer trunnion that increases head-sleeve contact area by 40%, strengthening connections and reducing micromovement at interfaces to minimize fretting corrosion risk.

• What components are included in the Fusion Taper System?

  The system includes Fusion trunnion and taper components, along with CoCr (Cobalt-Chromium) and Ceramic (Biolox Delta) heads that articulate with Logical XLPE liners in Logical Acetabular Cups. The heads have a 16/18 inner taper designed to connect to Ti6Al4V Fusion Taper Sleeves.

• What is the regulatory status of the Fusion Taper System?

  The Fusion Taper System is authorized under FDA 510(k) clearance with product code LZO. It received traditional clearance on April 16, 2021, after being submitted on April 21, 2020, and was determined to be substantially equivalent.

• How does the Fusion Taper System reduce the risk of fretting corrosion?

  The system features a longer trunnion than Signature Orthopaedics' previous taper system, which increases the head-sleeve contact area by 40%. This strengthened connection reduces micromovement at interfaces, thereby minimizing the risk of fretting corrosion.