510(k) · Cleared

Cleared

Medpor Ocular Screw and Acceossories

K971583510(k) TraditionalCleared Jun 30, 199761-day reviewClass II21 CFR 886.3320

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Porex Technologies Corp. · MQU Ocular Peg

Cleared on Jun 30, 1997 after a 61-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Jun 30, 1997
Review: 61 days
Class: Class II
Product code: MQU
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK971583 Medpor Ocular Screw and AcceossoriesPorex Technologies Corp. · 1997
Descendant · cites it directly · 0 of its ownK040851 Medpor Attractor Magnetic Coupling SystemPorex Surgical, Inc. · 2004
Descendant · cites it directly · 0 of its ownK974203 Perry-Kolberg (PK) Titanium Motility/Support SystemIntegrated Orbital Implants, Inc. · 1998 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K040851Medpor Attractor Magnetic Coupling SystemPorex Surgical, Inc. · 2004 · cites it directly0descendants
K974203Perry-Kolberg (PK) Titanium Motility/Support SystemIntegrated Orbital Implants, Inc. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K971583	Medpor Ocular Screw and Acceossories	Porex Technologies Corp.	1997	—
+1	K040851	Medpor Attractor Magnetic Coupling System	Porex Surgical, Inc.	2004	—
+1	K974203	Perry-Kolberg (PK) Titanium Motility/Support System	Integrated Orbital Implants, Inc.	1998	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2004	1	0

FIG. 1 — Lineage of K971583, 1997–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MQU? 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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	—	Ocular Screw and Accessories Named without a submission number			—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040851	Medpor Attractor Magnetic Coupling System	Porex Surgical, Inc.	2004	0
K974203	Perry-Kolberg (PK) Titanium Motility/Support System	Integrated Orbital Implants, Inc.	1998	0

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?

Of its descendants, K040851 (Porex Surgical, Inc., 2004) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MQU devices

MQU Ocular Peg: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQU

FDA has decided no MQU device since 2007.

Median 510(k) review, days · MQU

Too few MQU 510(k)s in any year since 2007 to give a median.

Recalls per year · MQU

No recall names MQU since 2007.

Adverse event reports per year · MQU

1in 2010

2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code MQU, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	1
2011	—	0
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	—	—

What is it indicated for?

The MCP® is indicated for patients with MEDPOR® Ocular Implants, who desire improved prosthetic eye motility via direct coupling of the implant to the prosthetic eye. Primary placement of the MCP® may occur during the initial reconstruction procedure, following attachment of the extraocular muscles to the ocular implant but before closing the Tenon’s capsule and the conjunctiva layer. Secondary placement of the MCP may occur typically 3-6 months post enucleation after the ocular implant has become vascularized. Please read additional instructions below.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971583 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971583: Medpor Ocular Screw and Acceossories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971583

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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