# K183532: Latitud Hip Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Meril Healthcare Pvt., Ltd.
- Decided: Jul 18, 2019 after 211 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: 14 generations back to K810258 (1981). 201 ancestors in all.
No later device cites it as a predicate yet.
0 of 201 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180973: Libertas Hip Replacement System, Maxx Orthopedics, Inc. (2018) Summary page 5.
- K110087: Corin Trinity Acetbular System with Hxlpe Liners, Corin USA (2011) 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.
- K103384: Escalade Acetabular Cup System, Ortho Development (2011) Summary page 5.
- K101086: Taperloc Complete, Biomet, Inc. (2010) Summary page 5.
- K062994: Lateralized Taperloc Microplasty Femoral Components, Biomet Manufacturing Corp (2007) Summary page 5.
- K103755: Taperloc Complete, Size 5 and 6, Biomet Manufacturing Corp (2011) Summary page 5.
- K120030: Taperloc Complete Size 4MM and XR 123, Biomet Manufacturing Corp (2012) Summary page 5.
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 5.
- K921301: Taperloc Femoral Stem and Universal Acetabular Com, Biomet, Inc. (1994) Summary page 5.
- K110400: Taperloc Complete Microplasty Stem, Biomet Manufacturing Corp (2011) Summary page 5.

## Indications for use
The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is an evidence of sufficient sound bone to fix and support the components. Total hip replacement is indicated for the following conditions: • Non-inflammatory degenerative joint diseases including osteoarthritis, post-traumatic arthritis and avascular necrosis. • Rheumatoid arthritis. • Congenital hip dysplasia. • Acute traumatic fracture of the femoral head or neck. • Certain cases of Ankylosis. • Dislocation of the hip. • Correction of functional deformity. • Revision of failed joint reconstruction or treatment. • Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur. Note: • The Titanium coated Modular Acetabular Shell is intended for press-fit, uncemented use only. • The Hydroxyapatite coated Uncemented Femoral Stem is intended for press-fit, uncemented use only. • The Proximally coated Uncemented femoral stem is intended for press-fit, uncemented use only. • The Cemented Femoral stem is intended for cemented use only. • The Modular Acetabular Liner is intended for use with Modular Acetabular Shell. • The CoCr Modular Femoral Head is intended to articulate with Modular Acetabular Liner to mate with uncemented stem or cemented stem. • The Biolox® delta Modular Femoral Head is intended to articulate with Modular Acetabular Liner and to mate with uncemented stem or cemented stem. • The Bone Screw and Apical Hole Occluder are intended for use with Modular Acetabular shell. • The Centralizer and Cement Restrictor are intended for use with cemented stem only.

Source page: https://510kreport.com/device/K183532
Methodology: https://510kreport.com/methodology