Martinez Orbital Implant
by Miguel Martinez M.D. 510(k)
Active
510(k) K935251
Overview
The Martinez Orbital Implant is an eye sphere implant designed for use following the evisceration or enucleation of an eye. It features a core with a layer of porous hydroxylapatite granules to promote incorporation into the fibro-vascular tissue of the eye.
This device is regulated under FDA 510(k) clearance K935251. It is classified as an ophthalmic device under regulation number 886.3320.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK935251 | Date1 Mar 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HPZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.3320
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
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Questions
What is the primary purpose of the Martinez Orbital Implant?
This device is an eye sphere implant intended for use by surgeons following the evisceration or enucleation of an eye. It serves as a structural replacement to maintain orbital volume.
How does the implant integrate with the patient's tissue?
The device features a core layer of porous hydroxylapatite granules. This specific material composition is designed to promote the incorporation of the implant into the patient's fibro-vascular tissue.
What is the regulatory status of this device?
The Martinez Orbital Implant is regulated under FDA 510(k) clearance number K935251. It is classified as an ophthalmic device under regulation number 886.3320.