FDA applicant
Portland Orthopaedics Pty., Ltd.
FDA records 6 decisions for Portland Orthopaedics Pty., Ltd. (Stillwater, MN) from 2000 to 2007: 6 510(k) clearances. Most are in product codes MEH (Prosthesis, Hip, Semi-Constrained, Uncemented…) and MAY (Prosthesis, Hip, Semi-Constrained…). Its devices cite 9 predicates, 1 of them its own earlier devices. 71 recalls are linked to its devices.
FDA’s records also spell it “Portland Orthopaedics Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Portland Orthopaedics Pty., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2007
2026 so far, outlined.
Recalls per year
71in 2008
Class I Class II/III not classified
Planning a device like Portland Orthopaedics Pty., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Portland”
FDA records each applicant name separately; these may or may not be the same firm.