# K183365: Libertas Acetabular Hooded Liner

- Pathway: 510(k) (Special)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Feb 22, 2019 after 80 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K192989: Libertas E-XLPE Modular Liner (2020), 0 descendants of its own

## Indications for use
The Libertas™ Acetabular Hooded Liner is intended for use in total hip arthroplasty, in conjunction with the Libertas™ Hip Replacement System. 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/K183365
Methodology: https://510kreport.com/methodology