# K180973: Libertas Hip Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Sep 28, 2018 after 168 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: 13 generations back to K810258 (1981). 133 ancestors in all.
3 later devices descend from it; 3 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)
- K172857: Latitud Hip Replacement System, Meril Healthcare Pvt., Ltd. (2018). Cleared while this submission was under review Summary page 5.
- K110087: Corin Trinity Acetbular System with Hxlpe Liners, Corin USA (2011) Summary page 5.
- K103120: Corin Biolox Delta Femoral Heads, Corin USA (2011) Summary page 5.
- K130343: Corin Trinity Acetabular System with Extra-Long Heads, Corin USA (2013) Summary page 5.
- K111481: Corin Trinity Acetabular System Ecima Liners, Corin USA (2012) Summary page 5.
- K093472: Trinity Acetabular System, Corin USA (2010) Summary page 5.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 5.
- K110290: Exeter Hip Stem, Howmedica Osteonics Corp. (2011) Summary page 5.
- K933077: Exeter Intramedullary Bone Plug, Howmedica Corp. (1995) Summary page 5.
- K974054: Distal Centralizer, Exeter II Hip System, Howmedica, Inc. (1997) Summary page 5.

## Most influential descendants
- K253171: Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (2026), 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 Libertas™ 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 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 nonunion, femoral neck and trochanteric fractures of the proximal femur. NOTE: • The Modular Shell and Uncemented Stem are intended for press-fit, uncemented use only. • The Cemented stem is intended for cemented use only.

Source page: https://510kreport.com/device/K180973
Methodology: https://510kreport.com/methodology