K120038 is an FDA 510(k) clearance for the A200 KNEE SYSTEM. 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 Renovis Surgical Technologies, LLC (San Diego, US). The FDA issued a Cleared decision on February 14, 2013, 406 days after receiving the submission on January 5, 2012.
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 | K120038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2012 |
| Decision Date | February 14, 2013 |
| Days to Decision | 406 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. |