Cleared Traditional

Libertas E-XLPE Modular Liner

K192989 · Maxx Orthopedics, Inc. · Orthopedic
Oct 2020
Decision
370d
Days
Class 2
Risk

About This 510(k) Submission

K192989 is an FDA 510(k) clearance for the Libertas E-XLPE Modular Liner, a Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented (Class II — Special Controls, product code OQI), submitted by Maxx Orthopedics, Inc. (Norristown, US). The FDA issued a Cleared decision on October 29, 2020, 370 days after receiving the submission on October 25, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number K192989 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2019
Decision Date October 29, 2020
Days to Decision 370 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OQI — Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3353
Definition 1. Non-inflammatory Degenerative Joint Disease Including Osteoarthritis And Avascular Necrosis. 2. Rheumatoid Arthritis. 3. Correction Of Functional Deformity. 4. Treatment Of Non-union, Femoral Neck Fracture, And Trochanteric Fractures Of The Proximal Femur With Head Involvement, Unmanageable By Other Techniques. 5. Revision Procedures Where Other Treatment Or Devices Have Failed. Cemented And Uncemented Use.