K042565 is an FDA 510(k) clearance for the ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II - Special Controls, product code LPH).
Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on April 11, 2005, 202 days after receiving the submission on September 21, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K042565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2004 |
| Decision Date | April 11, 2005 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3358 |