# K162125: MALUC™ Total Hip Arthroplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Surgtech, Inc.
- Decided: May 10, 2017 after 282 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: 6 generations back to K941141 (1994). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023453: Depuy Summit FX Cemented Hip Prosthesis, DePuy Orthopaedics, Inc. (2002) Summary page 4.
- K011623: Exeter Hip System with V40 Taper, Howmedica Osteonics Corp. (2001) Summary page 4.
- K032300: Accolade-J Hip Stem Series, Howmedica Osteonics Corp. (2003) Summary page 4.
- K040412: Trident T Acetabular Shells, Stryker Orthopaedics (2004) Summary page 4.
- K991952: Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts, Howmedica Osteonics Corp. (1999) Summary page 4.
- K022077: 36MM V40 Femoral Head Components (Lfit and Non-Lfit), Howmedica Osteonics Corp. (2002) Summary page 4.
- K010757: Lfit V40 Femoral Head Components, Howmedica Osteonics Corp. (2001) Summary page 4.
- K070885: Universal Taper Delta Femoral Head, Howmedica Osteonics Corp. (2007) Summary page 4.
- K000306: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 4.

## Indications for use
The SurgTech MALUC™ System is intended for use for cases of severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty and/or total arthroplasty), and certain cases of ankylosis.

Source page: https://510kreport.com/device/K162125
Methodology: https://510kreport.com/methodology