# K140547: Excera Fitrite Total Hip Arthroplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Excera Orthopedics, Inc.
- Decided: Jan 22, 2015 after 324 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K850055 (1985). 68 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061461: Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05, Zimmer, Inc. (2006) Summary page 4.
- K030265: CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00, Zimmer, Inc. (2003) Summary page 4.
- K071723: Zimmer Porolock Mis Stem, Zimmer GmbH (2008) Summary page 4.
- K071784: Depuy Pinnacle with Gripton Acetabular Cups, DePuy Orthopaedics, Inc. (2007) Summary page 5.
- K001534: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 5.
- K033273: Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima Unipolar Femoral Heads, DePuy Orthopaedics, Inc. (2004) Summary page 5.
- K922247: Kinamed Reality Total Hip System, Kinamed, Inc. (1994) Summary page 5.

## Most influential descendants
- K153057: FitRite™ Total Hip Arthroplasty System (2016), 0 descendants of its own

## Indications for use
Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The Excera FitRite™ Total Hip Arthroplasty System is indicated for total hip replacement in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The FitRite™ DDH Femoral Stems, Standard Femoral Stems, and Acetabular Cups are intended for cementless application; the FitRite™ Cemented Femoral Stems are intended for cemented application.

Source page: https://510kreport.com/device/K140547
Methodology: https://510kreport.com/methodology