# K192989: Libertas E-XLPE Modular Liner

- Pathway: 510(k) (Traditional)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Oct 29, 2020 after 370 days
- Product code: OQI (Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, 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). 135 ancestors in all.
No later device cites it as a predicate yet.
0 of 135 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.
- K183365: Libertas Acetabular Hooded Liner, Maxx Orthopedics, Inc. (2019) Summary page 5.

## 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, Uncemented Stem and Taper Uncemented Femoral Stem are intended for press-fit, uncemented use only. • The Cemented stem is intended for cemented use only.

Source page: https://510kreport.com/device/K192989
Methodology: https://510kreport.com/methodology