# K201047: Fusion Taper System

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Apr 16, 2021 after 360 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K941847 (1994). 252 ancestors in all.
No later device cites it as a predicate yet.
1 of 252 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073567: Biolox Option Ceramic Femoral Head System, Model 8777 Series, Zimmer GmbH (2008) Summary page 4.
- K143184: Evolve UniPolar Head, Signature Orthopaedics Pty, Ltd. (2015) Summary page 4.
- K190704: Signature Ceramic Femoral Head, Signature Orthopaedics Pty, Ltd. (2019) Summary page 4.

## Indications for use
Signature Orthopaedics' Fusion Taper System is intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: * Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis * Inflammatory joint disease including rheumatoid arthritis * Correction of functional deformity including congenital hip dysplasia * Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture * Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemi-arthroplasty, surface replacement, or total replacement Signature Orthopaedics' Fusion Taper System is intended for cementless fixation only.

Source page: https://510kreport.com/device/K201047
Methodology: https://510kreport.com/methodology