Medpor Surgical Implant Material

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

510(k) Number

K943275 ↗

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 Quad Motility Implant

  Class II

  FDA 510(k) K010902 Active Cleared 19 Jun 2001

• 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 types of ophthalmic surgical procedures is the Medpor Surgical Implant Material intended for, and why is it specifically designed for these uses?

  The Medpor Surgical Implant Material is designed for ophthalmic procedures requiring biocompatible, tissue-integrating materials, such as orbital reconstructions or structural support in eye socket surgeries. Its porous polyethylene composition facilitates integration with host tissue, providing stable structural support or augmentation where precise biocompatibility is critical. This makes it ideal for applications like orbital floor repairs or orbital volume restoration, where long-term stability and tissue compatibility are essential.

• Is the Medpor Surgical Implant Material reusable, or is it intended for single-use only? How does this affect its sterility and handling?

  The Medpor Surgical Implant Material is explicitly supplied as a sterile, single-use implant. This design ensures patient safety by eliminating the risk of cross-contamination or degradation from repeated sterilization processes. Clinicians must use each implant only once and adhere to sterile handling protocols to maintain its integrity and sterility before surgical use.

• What regulatory pathway was followed for FDA clearance of the Medpor Surgical Implant Material, and what does ‘substantially equivalent’ mean in this context?

  The Medpor Surgical Implant Material received FDA 510(k) clearance (K943275) under the Traditional 510(k) Review pathway, classified as an Implant, Eye Sphere under Product Code HPZ. The term *‘substantially equivalent’* means the device was determined to have the same intended use and technological characteristics as a legally marketed predicate device (a previously cleared implant) while meeting FDA safety and effectiveness requirements. This classification ensures it adheres to established standards for ophthalmic implants.

• Are there different sizes or models of the Medpor Surgical Implant Material available, and how would a clinician determine the correct size for a patient?

  While the provided data does not list specific sizes or models, the Medpor Surgical Implant Material is designed for customizable sizing to match individual patient anatomy in ophthalmic reconstructions. Clinicians typically select or customize the implant based on preoperative measurements (e.g., orbital dimensions) and surgical goals, such as restoring volume or structural integrity. The porous polyethylene material allows for flexibility in shaping during surgery to achieve the desired fit.

• How should the Medpor Surgical Implant Material be stored, and what precautions should be taken to preserve its sterility and performance?

  As a sterile, single-use implant, the Medpor Surgical Implant Material should be stored in its original, unopened packaging in a clean, dry environment protected from moisture, extreme temperatures, and direct sunlight. The packaging is designed to maintain sterility until immediate preoperative use. Clinicians must follow manufacturer guidelines to avoid contamination and ensure the implant remains intact for optimal surgical performance.