# K183684: Libertas – Taper Uncemented Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Aug 23, 2019 after 238 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: 8 generations back to K850055 (1985). 75 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120030: Taperloc Complete Size 4MM and XR 123, Biomet Manufacturing Corp (2012) Summary page 4.
- K110400: Taperloc Complete Microplasty Stem, Biomet Manufacturing Corp (2011) Summary page 4.
- K103755: Taperloc Complete, Size 5 and 6, Biomet Manufacturing Corp (2011) Summary page 4.
- K101086: Taperloc Complete, Biomet, Inc. (2010) Summary page 4.
- K062994: Lateralized Taperloc Microplasty Femoral Components, Biomet Manufacturing Corp (2007) Summary page 4.
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 4.
- K921301: Taperloc Femoral Stem and Universal Acetabular Com, Biomet, Inc. (1994) Summary page 4.

## Most influential descendants
- K253171: Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (2026), 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, Uncemented Stem and Taper 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/K183684
Methodology: https://510kreport.com/methodology