# K201519: PROFEMUR® GLADIATOR® Cemented Classic Stem

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Dec 10, 2020 after 185 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K935452 (1994). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111910: Gladiator Hip Stem, Wrightmedicaltechnologyinc (2011) Summary page 4.
- K091423: Profemur Hip System Modular Necks, Wrightmedicaltechnologyinc (2009) Summary page 4.
- K100866: Profemur Hip System Modular Necks, Wrightmedicaltechnologyinc (2010) Summary page 4.

## Most influential descendants
- K213816: MPO Hip Instruments (2022), 0 descendants of its own

## Indications for use
PROFEMUR® GLADIATOR® Cemented Classic Stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. 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 PROFEMUR® GLADIATOR® Cemented Classic Stems are single use implants intended for cemented arthroplasty.

Source page: https://510kreport.com/device/K201519
Methodology: https://510kreport.com/methodology