Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Portland Orthopaedics Pty. , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
146 daysmedian FDA review time
224 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061564 | PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD | Portland Orthopaedics Pty. , Ltd. | 2006-09-01 | 88 | 0 |
| K053417 | M-COR HIP REPLACEMENT SYSTEM | Portland Orthopaedics Pty. , Ltd. | 2006-07-20 | 224 | 0 |
| K051844 | EQUATOR PLUS ACETABULAR CUP SYSTEM | Portland Orthopaedics Pty. , Ltd. | 2005-10-07 | 92 | 0 |
| K032641 | MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM | Portland Orthopaedics Pty. , Ltd. | 2004-01-20 | 146 | 71 |
| K992815 | THE MARGRON HIP REPLACEMENT SYSTEM | Portland Orthopaedics Pty. , Ltd. | 2000-02-07 | 171 | 71 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda