510(k) Report

FDA applicant

Porex Surgical, Inc.

Newnan, GA19 decisions1994–20117 recalls

FDA records 19 decisions for Porex Surgical, Inc. (Newnan, GA) from 1994 to 2011: 19 510(k) clearances. Most are in product codes HPZ (Implant, Eye Sphere) and FWP (Prosthesis, Chin, Internal). Its devices cite 20 predicates, 1 of them its own earlier devices. 7 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 Porex Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 12009: 12010: 32011: 1
2007high 3 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2021

2008: 12011: 12012: 12014: 32021: 1
2007high 3 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Porex Surgical, 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 Sphere6decisions
  • FWPProsthesis, Chin, Internal2decisions
  • NPKBarrier, Synthetic, Intraoral2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • FTMMesh, Surgical1decision
  • JOFPolymer, Ent Synthetic, Porous Polyethylene1decision

Also: OKS (1), HQN (1), JEY (1), HBW (1), GXP (1), LYA (1).

Whose devices does it build on?

Its devices cite 20 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 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.

  • K083621Medpor Customized Surgical ImplantPorex Surgical, Inc. · 20095cite it
  • K040364Medpor Craniofacial Implants with Embedded Titanium MeshPorex Surgical, Inc. · 20043cite it
  • K021357Medpor Plus Orbital Volume Replacement ImpantPorex Surgical, Inc. · 20023cite it
  • K012350Medpor Plus Surgical Implant BiomaterialPorex Surgical, Inc. · 20021cites it
  • K954939Medpor Ocular Screw & AccessoriesPorex Surgical, Inc. · 19961cites it
  • K010902Medpor Quad Motility ImplantPorex Surgical, Inc. · 20011cites it

What has FDA decided for it lately?

  • 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
  • K071335Medpor Attractor ImplantPorex Surgical, Inc. · 2007
  • K052297Porex Electrosurgery NeedlePorex Surgical, Inc. · 2006
  • K040851Medpor Attractor Magnetic Coupling SystemPorex Surgical, Inc. · 2004

All 19 as Porex Surgical, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K040364MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032Dec 29, 2021Class II
  • K040364MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right…Dec 17, 2014Class II
  • K952677MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and…Dec 17, 2014Class II
  • K952677MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block…Dec 17, 2014Class II
  • K021357MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road, Newnan…Mar 20, 2012
  • K040364MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR…Dec 16, 2011

Other applicant names beginning “Porex”

FDA records each applicant name separately; these may or may not be the same firm.

Porex Medical 15Porex Technologies Corp. 2Porex Technologies Corp. of Georgia 2Porex Medical Products 1Porex Surgical Products Group 1