510(k) · Cleared
ClearedEquator Plus Acetabular Cup System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portland Orthopaedics Pty., Ltd. · MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Cleared on Oct 7, 2005 after a 92-day review. The FDA summary names no predicate by number.
- Decided
- Oct 7, 2005
- Review
- 92 days
- Class
- Class II
- Product code
- MAY
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MAY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MAY devicesMAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAY
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · MAY
Too few MAY 510(k)s in any year since 2007 to give a median.
Recalls per year · MAY
15in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAY
2in 2025
MAUDE reports naming product code MAY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 29 |
| 2013 | 1 | — | 0 | 45 |
| 2014 | 0 | — | 0 | 94 |
| 2015 | 0 | — | 0 | 115 |
| 2016 | 0 | — | 15 | 60 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Equator PIusTM Acetabular Cup System has the following indications for use: * The patient should be skeletally mature. * The patient's condition should be due to one or more of the following: 1. Osteoarthritis. 2. Rheumatoid arthritis. 3. Tumor conditions involving the upper third of the femur or of the Acetabular. 4. Ankylosing spondylitis. 5. Psoriatic arthritis. 6. Old osteomyelitis - with a long infection-free period and a normal WBC, ESR and…
Read the full statement (152 words)
The Equator PIusTM Acetabular Cup System has the following indications for use:
* The patient should be skeletally mature.
* The patient's condition should be due to one or more of the following:
1. Osteoarthritis.
2. Rheumatoid arthritis.
3. Tumor conditions involving the upper third of the femur or of the Acetabular.
4. Ankylosing spondylitis.
5. Psoriatic arthritis.
6. Old osteomyelitis - with a long infection-free period and a normal WBC, ESR and C-reactive protein.
7. Non union of femoral neck fracture or avascular necrosis of the femoral head.
8. Post-traumatic fracture/dislocation of the hip.
9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051844 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051844: Equator Plus Acetabular Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051844
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026