Medpor Quad Motility Implant

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K010902 ↗

FDA Product Code

HPZ

Device Class

Class II

Regulation

21 CFR Part 886.3320

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Medpor Surgical Granule Implants

  Class II

  FDA 510(k) K982040 Active Cleared 8 Sep 1998

• Porex Nostril Retainers

  Class I

  FDA 510(k) K981374 Active Cleared 2 Jul 1998

• Medpor Surgical Implant Material

  Class II

  FDA 510(k) K943275 Active Cleared 2 Sep 1994

• Medpor Craniofacial Implants with Embedded Titanium Mesh

  Class II

  FDA 510(k) K040364 Active Cleared 30 Jun 2004

• Medpor Plus Orbital Volume Replacement Impant

  Class II

  FDA 510(k) K021357 Active Cleared 5 Aug 2002

• Porex Electrosurgery Needle

  Class II

  FDA 510(k) K052297 Active Cleared 28 Mar 2006

See all devices from Porex Surgical, Inc. →

• What is the MEDPOR QUAD MOTILITY IMPLANT used for?

  The MEDPOR QUAD MOTILITY IMPLANT is an eye sphere implant intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left, as it is designed for ophthalmic use in post-enucleation or evisceration procedures to maintain orbital volume.

• How is the MEDPOR QUAD MOTILITY IMPLANT supplied and is it sterile or reusable?

  The MEDPOR QUAD MOTILITY IMPLANT is supplied as a sterile, single-use implant for ophthalmic use, meaning it is provided in a sterile condition and intended for one-time implantation only, with no reuse permitted to ensure patient safety and maintain sterility integrity.

• What regulatory clearance does the MEDPOR QUAD MOTILITY IMPLANT have and when was it granted?

  The MEDPOR QUAD MOTILITY IMPLANT received FDA 510(k) clearance under K-number K010902 on June 19, 2001, and is classified as a Class II medical device under regulation number 886.3320, confirming its substantial equivalence to a legally marketed predicate device.