510(k) Report

510(k) · Cleared

Recalled · 2006

Perry-Kolberg (PK) Titanium Motility/Support System

K974203510(k) TraditionalCleared Feb 4, 199886-day reviewClass II21 CFR 886.3320Recalls 1

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

Integrated Orbital Implants, Inc. · MQU Ocular Peg

Cleared on Feb 4, 1998 as substantially equivalent to K971583 (Porex Technologies Corp., 1997) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1996. It has been recalled once.

Decided
Feb 4, 1998
Review
86 days
Class
Class II
Product code
MQU
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K954939 (1996). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 1 other ancestorK954939 · Medpor Ocular Screw & Accessories · Porex Surgical, Inc. · 1996199619982000
Other ancestors, by generation 1 generation back: 2 other ancestors K954939 · Medpor Ocular Screw & Accessories · Porex Surgical, Inc. · 19960
  1. Root · 1 generation backK954939 Medpor Ocular Screw & AccessoriesPorex Surgical, Inc. · 1996
  2. This deviceK974203 Perry-Kolberg (PK) Titanium Motility/Support SystemIntegrated Orbital Implants, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K954939Medpor Ocular Screw & AccessoriesPorex Surgical, Inc.1996—
0 (this device)K974203Perry-Kolberg (PK) Titanium Motility/Support SystemIntegrated Orbital Implants, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
FIG. 1 — Lineage of K974203, 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), 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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K971583Medpor Ocular Screw and Acceossories
Summary page 1
…82, as Class II devices. Therefore, they are reviewed as Class II devices. A new Product Code recently assigned to one of the predicate devices, the MEDPOR Ocular Screw (K971583) is MQU. The PK Titanium Threaded Sleeve Wrench and PK Titanium Needle Drill Handles used with the PK Titanium Motility/Support…
Porex Technologies Corp.1997—
*K960859Medpor Ocular Peg System and Accessories
Summary page 3
…been determined by FDA to be substantially equivalent to pre-amendment devices: MEDPOR Ocular Screw and Accessories (K971583), MEDPOR Ocular Peg System and Accessories (K960859), MEDPOR Ocular Screw and Accessories (K954939). T 2072, 510(k) SUMMARY Perry-Kolberg Titanium Motility/Support…
Porex Technologies Corp. of Georgia1996—
*K954939Medpor Ocular Screw & Accessories
Summary page 3
…valent to pre-amendment devices: MEDPOR Ocular Screw and Accessories (K971583), MEDPOR Ocular Peg System and Accessories (K960859), MEDPOR Ocular Screw and Accessories (K954939). T 2072, 510(k) SUMMARY Perry-Kolberg Titanium Motility/Support System Page 4 Intended Use The indications fo…
Porex Surgical, Inc.1996—

Also cleared against K971583: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 20, 2006Not classifiedZ-0396-2007OtherThe threads on the threaded sleeve were manufactured with left-handed threads, requiring a modification to the surgical technique for proper insertion. Failure to properly identify the affected components and apply the modified insertion…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • 1 other device also cites its predicate K971583.

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

2010: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Perry-Kolberg Titanium Motility/Support System is intended to provide a direct mechanical coupling of an ocular prosthesis to an orbital implant (eye sphere implant) in order to enhance motility of the prosthesis over that of a prosthesis used without a direct coupling to the implant. It also reduces the weight of the ocular prosthesis on the lower eyelid. It may be placed in a secondary operation that occurs after the ocular implant has become vascularized, approximately three to six months after implant placement. Alternatively, it may be placed during the initial implantation procedure before closing the Tenon’s capsule and the conjunctiva.

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

Also cleared against K971583

1 other device cites the same predicate.

  • K040851Medpor Attractor Magnetic Coupling SystemPorex Surgical, Inc. · 2004

More from Integrated Orbital Implants, Inc.

5 FDA decisions under this applicant name. See the company

  • K003338Bio-Eye II Orbital ImplantIntegrated Orbital Implants, Inc. · 20011 recall
  • K000151Perry-Kolberg (PK) HA-Coated Titanium SleeveIntegrated Orbital Implants, Inc. · 2000
  • K982562Bio-Eye Hydroxyapatite Ocular Impland and ConformerIntegrated Orbital Implants, Inc. · 19982 recalls
  • K891137Motility Orbital ImplantIntegrated Orbital Implants, Inc. · 1989

Recent decisions in MQU

The MQU category page

  • K000151Perry-Kolberg (PK) HA-Coated Titanium SleeveIntegrated Orbital Implants, Inc. · 2000
  • K980822Titanium Peg SystemFci Ophthalmics, Inc. · 1998
  • K971583Medpor Ocular Screw and AcceossoriesPorex Technologies Corp. · 1997

https://510kreport.com/device/K974203 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974203: Perry-Kolberg (PK) Titanium Motility/Support System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974203

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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