K201315 is an FDA 510(k) clearance for the PERFORM Humeral System – Stem. This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer + Additive, Cemented (Class II - Special Controls, product code PAO).
Submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on September 11, 2020, 116 days after receiving the submission on May 18, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660. Total Shoulders Are Indicated For Arthritis (osteo-, Rheumatoid, Traumatic), Avascular Necrosis, Correction Of Functional Deformity, And Revision Procedures..
| 510(k) Number | K201315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2020 |
| Decision Date | September 11, 2020 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PAO — Prosthesis, Shoulder, Semi-constrained, Metal/polymer + Additive, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |
| Definition | Total Shoulders Are Indicated For Arthritis (osteo-, Rheumatoid, Traumatic), Avascular Necrosis, Correction Of Functional Deformity, And Revision Procedures. |