Portland Orthopaedics Pty. , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Portland Orthopaedics Pty. , Ltd.” (first 2000, latest 2006), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 146 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 | 1 |
| MAY | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Portland Orthopaedics Pty. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061564 | PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD | LZO | 2006-09-01 | 88 |
| K053417 | M-COR HIP REPLACEMENT SYSTEM | LPH | 2006-07-20 | 224 |
| K051844 | EQUATOR PLUS ACETABULAR CUP SYSTEM | MAY | 2005-10-07 | 92 |
| K032641 | MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM | MEH | 2004-01-20 | 146 |
| K992815 | THE MARGRON HIP REPLACEMENT SYSTEM | MEH | 2000-02-07 | 171 |
Recalls
71 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-01-11.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Portland Orthopaedics Limited (1 510(k)s)
- Portland Welding Supply, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Portland Orthopaedics Pty. , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Portland Orthopaedics Pty. , Ltd.” (first 2000, latest 2006), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Portland Orthopaedics Pty. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Portland Orthopaedics Pty. , Ltd. is 146 days.
Which FDA product codes appear under Portland Orthopaedics Pty. , Ltd.?
The most frequent FDA product codes under this applicant name are MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, 2); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 1); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 1).
Next steps
- See all 5 Portland Orthopaedics Pty. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MEH, Portland Orthopaedics Pty. , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.