510(k) · Cleared
ClearedMedpor Attractor Magnetic Coupling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porex Surgical, Inc. · HPZ Implant, Eye Sphere
Cleared on Jul 16, 2004 as substantially equivalent to K971583 (Porex Technologies Corp., 1997) and 1 other predicate after a 107-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jul 16, 2004
- Review
- 107 days
- Class
- Class II
- Product code
- HPZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K960859 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK960859 Medpor Ocular Peg System and AccessoriesPorex Technologies Corp. of Georgia · 1996
- This deviceK040851 Medpor Attractor Magnetic Coupling SystemPorex Surgical, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960859 | Medpor Ocular Peg System and Accessories | Porex Technologies Corp. of Georgia | 1996 | — |
| 0 (this device) | K040851 | Medpor Attractor Magnetic Coupling System | Porex Surgical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
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 HPZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HPZ device
- #1 K212741 Ezyporscore 3.6 · 1 generation · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971583 | Medpor Ocular Screw and AcceossoriesSummary page 1…gnetic Coupling System (MCS) Class If Device 51 0(k) Number ________ Substantially equivalent to: A. MEDPOR Ocular Peg System K971583 B. MEDPOR Ocular Screw K960859 Device description: Titanium nitride coated stainless steel screw, A… | 1997 |
| * | K960859 | Medpor Ocular Peg System and AccessoriesSummary page 1…ice 51 0(k) Number ________ Substantially equivalent to: A. MEDPOR Ocular Peg System K971583 B. MEDPOR Ocular Screw K960859 Device description: Titanium nitride coated stainless steel screw, ATTRACTOR SCREW, is designed… | 1996 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K971583.
How does its category compare?
All HPZ devicesHPZ Implant, Eye Sphere: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HPZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HPZ
Too few HPZ 510(k)s in any year since 2007 to give a median.
Recalls per year · HPZ
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HPZ
6in 2011
MAUDE reports naming product code HPZ, 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 | 2 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 0 | — | 1 | 3 |
| 2011 | 2 | — | 0 | 6 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MEDPOR ATTRACTOR Magnetic Coupling System is indicated for patients who have a MEDPOR Ocular Implant, and wish to gain improved prosthetic eye motility by coupling the ocular Implant to the prosthetic eye.
NOTE: Improved prosthesis motility is a function of adequate Implant motility, adequate coupling forces between the Implant and the prosthesis, and adequate room in the socket for prosthesis motility. Not all patients will benefit from the use of the MEDPOR Attractor Magnetic Coupling System. Consider all factors affecting potential prosthesis motility when selecting patients for the MEDPOR ATTRACTOR Magnetic Coupling System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040851: Medpor Attractor Magnetic Coupling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040851
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026