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K Number
K180973
Device Name
Libertas Hip Replacement System
Manufacturer
Maxx Orthopedics, Inc
Date Cleared
2018-09-28

(168 days)

Product Code
JDI,LZO
Regulation Number
888.3350
Type
Traditional
Panel
OR
Reference & Predicate Devices
K000306,K033273,K172857,K110087,K103120,K130343,K111481,K093472,K042992,K110290,K933077,K974054
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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 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.
Device Description

The Libertas™ Hip Replacement System consists of the following components:

  • Acetabular Cup System
    • Modular Shell
    • Modular Liner HXLPE
    • Cobalt Chromium alloy Modular Femoral Head
    • Biolox® delta Modular Femoral Head
  • Femoral Stem
    • Uncemented Femoral Stem
    • Cemented Femoral Stem
  • Accessories (Sub components)
    • Bone Screw
    • Apical Hole Occluder
    • Centralizer
    • Cement Restrictor
    • Screw Hole Occluder
AI/ML Overview

This document describes the Libertas™ Hip Replacement System, a medical device for total hip arthroplasty, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria or detailed performance data in the format requested.

Therefore, I cannot provide the requested table of acceptance criteria and device performance, nor the details regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The document primarily focuses on establishing substantial equivalence through non-clinical performance testing and similarity to predicate devices, rather than a clinical study with detailed acceptance criteria and performance metrics.

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.