K100048 is an FDA 510(k) clearance for the E1 ANTIOXIDANT INFUSED TECHNOLOGY. This device is classified as a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive (Class II - Special Controls, product code OIY).
Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on March 9, 2010, 60 days after receiving the submission on January 8, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560. Indicated For: 1. Painful And Disabled Knee Joint Resulting From Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis Where One Or More Compartments Are Involved. 2. Correction Of Varus, Valgus, Or Posttraumatic Deformity. 3. Correction Or Revision Of Unsuccessful Osteotomy, Arthrodesis, Or Failure Of Previous Joint Replacement Procedure. For Cemented Use..
| 510(k) Number | K100048 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2010 |
| Decision Date | March 09, 2010 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OIY — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3560 |
| Definition | Indicated For: 1. Painful And Disabled Knee Joint Resulting From Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis Where One Or More Compartments Are Involved. 2. Correction Of Varus, Valgus, Or Posttraumatic Deformity. 3. Correction Or Revision Of Unsuccessful Osteotomy, Arthrodesis, Or Failure Of Previous Joint Replacement Procedure. For Cemented Use. |