# K172857: Latitud Hip Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Meril Healthcare Pvt., Ltd.
- Decided: Jul 19, 2018 after 302 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: 12 generations back to K810258 (1981). 131 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110087: Corin Trinity Acetbular System with Hxlpe Liners, Corin USA (2011) Summary page 6.
- K103120: Corin Biolox Delta Femoral Heads, Corin USA (2011) Summary page 6.
- K130343: Corin Trinity Acetabular System with Extra-Long Heads, Corin USA (2013) Summary page 6.
- K093472: Trinity Acetabular System, Corin USA (2010) Summary page 6.
- K000306: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 6.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 6.
- K110290: Exeter Hip Stem, Howmedica Osteonics Corp. (2011) Summary page 6.
- K980843: Exeter Intramedullary Bone Plug, Howmedica, Inc. (1998) Summary page 6.
- K974054: Distal Centralizer, Exeter II Hip System, Howmedica, Inc. (1997) Summary page 6.
- K960258: Natural Hip System, Intermedics Orthopedics (1996) Summary page 6.

## Most influential descendants
- K180973: Libertas Hip Replacement System (2018), 3 descendants of its own
- K253171: Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (2026), 0 descendants of its own
- K222436: Latitud™ Hip Replacement System (2023), 0 descendants of its own
- K192989: Libertas E-XLPE Modular Liner (2020), 0 descendants of its own
- K183532: Latitud Hip Replacement System (2019), 0 descendants of its own

## 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 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/K172857
Methodology: https://510kreport.com/methodology