K173583 is an FDA 510(k) clearance for the Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners. This device is classified as a Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented (Class II - Special Controls, product code OQI).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on March 12, 2018, 112 days after receiving the submission on November 20, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353. 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..
| 510(k) Number | K173583 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2017 |
| Decision Date | March 12, 2018 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| 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. |