510(k) Report

510(k) · Cleared

Cleared

Medpor Ocular Screw & Accessories

K954939510(k) TraditionalCleared Jan 25, 199687-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 Surgical, Inc. · HPZ Implant, Eye Sphere

Cleared on Jan 25, 1996 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jan 25, 1996
Review
87 days
Class
Class II
Product code
HPZ
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1995200020052010201520202025
  1. This deviceK954939 Medpor Ocular Screw & AccessoriesPorex Surgical, Inc. · 1996
  2. Descendant · cites it directly · 0 of its ownK974203 Perry-Kolberg (PK) Titanium Motility/Support SystemIntegrated Orbital Implants, Inc. · 1998 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954939Medpor Ocular Screw & AccessoriesPorex Surgical, Inc.1996—
+1K974203Perry-Kolberg (PK) Titanium Motility/Support SystemIntegrated Orbital Implants, Inc.19981

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K954939, 1996–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K212741 Ezyporscore 3.6 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K974203Perry-Kolberg (PK) Titanium Motility/Support SystemIntegrated Orbital Implants, Inc.19980

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, K974203 (Integrated Orbital Implants, Inc., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HPZ devices

HPZ Implant, Eye Sphere: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HPZ

1in 2022

2007: 22008: 12009: 22011: 22013: 12022: 1
2007high 2 (2007) · low 0 (2010)2026

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

2010: 12012: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HPZ

6in 2011

2007: 52008: 72009: 52010: 32011: 6
2007high 7 (2008) · low 0 (2012)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—05
20081—07
20092—05
20100—13
20112—06
20120—10
20131—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20221—00
20230—00
20240—00
20250—00
20260—0—

More from Porex Surgical, Inc.

19 FDA decisions under this applicant name. See the company

  • K102184Medpor Contain Can ImplantPorex Surgical, Inc. · 2011
  • K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010
  • K091807Medpor Fixation SystemPorex Surgical, Inc. · 2010
  • K091120Medpor Contain ImplantPorex Surgical, Inc. · 2010
  • K083621Medpor Customized Surgical ImplantPorex Surgical, Inc. · 2009

Recent decisions in HPZ

The HPZ category page

  • K212741EzyporFci (France Chirurgie Instrumentation) Sas · 2022
  • K123764Durette Ocular ImplantOculo-Plastik, Inc. · 2013
  • K110554Bioceramic Orbital Implant, OrbtexCeramisys, Ltd. · 2011
  • K112176Silicone SpheresOculo Plastik, Inc. · 2011
  • K083342Orbital Reconstructive Implant IIEvera Medical, Inc. · 2009

https://510kreport.com/device/K954939 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954939: Medpor Ocular Screw & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954939

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026