# K240452: Ceramic Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Apr 12, 2024 after 57 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: 11 generations back to K850055 (1985). 213 ancestors in all.
No later device cites it as a predicate yet.
3 of 214 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173776: BIOLOX delta Option and Extra-long Heads, Microport Orthopedics, Inc. (2018) Summary page 5.
- K190704: Signature Ceramic Femoral Head, Signature Orthopaedics Pty, Ltd. (2019) Summary page 5.
- K173898: MicroPort Orthopedics Total Hip Systems MR Labeling, Microport Orthopedics Inc. (Mpo) (2018) Summary page 5.

## Indications for use
MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K240452
Methodology: https://510kreport.com/methodology