510(k) Report

FDA applicant

Integrated Orbital Implants, Inc.

San Diego, CA5 decisions1989–20014 recalls

FDA records 5 decisions for Integrated Orbital Implants, Inc. (San Diego, CA) from 1989 to 2001: 5 510(k) clearances. Most are in product codes HPZ (Implant, Eye Sphere) and MQU (Ocular Peg). Its devices cite 6 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.

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

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Integrated Orbital Implants, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Integrated Orbital Implants, Inc. since 2007.

Recalls per year

1in 2011

2010: 12011: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Integrated Orbital Implants, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Integrated Orbital Implants, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HPZImplant, Eye Sphere3decisions
  • MQUOcular Peg2decisions

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K003338Bio-Eye II Orbital ImplantIntegrated Orbital Implants, Inc. · 20011cites it
  • K891137Motility Orbital ImplantIntegrated Orbital Implants, Inc. · 19891cites it
  • K982562Bio-Eye Hydroxyapatite Ocular Impland and ConformerIntegrated Orbital Implants, Inc. · 19981cites it

What has FDA decided for it lately?

  • 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
  • K974203Perry-Kolberg (PK) Titanium Motility/Support SystemIntegrated Orbital Implants, Inc. · 19981 recall
  • K891137Motility Orbital ImplantIntegrated Orbital Implants, Inc. · 1989

All 5 as Integrated Orbital Implants, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K003338Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. Product Generic Name…May 20, 2011
  • K982562Sterile Bio-Eye Hydroxyapatite Orbital Implant and ConformerJun 7, 2010
  • K974203Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model…Dec 20, 2006
  • K982562Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020SFeb 27, 2006