510(k) K192989
K192989 is an FDA 510(k) premarket notification submitted by Maxx Orthopedics, Inc. for the device "Libertas E-XLPE Modular Liner". The FDA issued a decision of Substantially Equivalent on October 29, 2020. The device falls under product code OQI (Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented), a Class II device regulated under 21 CFR 888.3353. Maxx Orthopedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2020
- Date Received
- October 25, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3353
- Review Panel
- OR
- Submission Type
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.