Cleared Traditional

K941717 - MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT

K941717 is an FDA 510(k) clearance for MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT, manufactured by Miguel Martinez M.D.. The device is a Class 2 Ophthalmic device with product code HPZ cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K941717 · Miguel Martinez M.D. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
313d
Days
Class 2
Risk

K941717 is an FDA 510(k) clearance for the MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Miguel Martinez M.D. (Tucson, US). The FDA issued a Cleared decision on February 14, 1995 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3320 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Miguel Martinez M.D. devices

FDA 510(k) Submission Details - K941717

510(k) Number K941717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1994
Decision Date February 14, 1995
Days to Decision 313 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 110d · This submission: 313d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HPZ Device Classification - Class 2, Special Controls

Product Code HPZ Implant, Eye Sphere
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HPZ Implant, Eye Sphere

All 20
Devices cleared under the same product code (HPZ) and FDA review panel - the closest regulatory comparables to K941717.
GORE SPHEREX IMPLANT
K962241 · W.L. Gore & Associates, Inc. · Aug 1996
MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES
K960859 · Porex Technologies Corp. of Georgia · May 1996
MEDPOR OCULAR SCREW & ACCESSORIES
K954939 · Porex Surgical, Inc. · Jan 1996
MEDPOR SURGICAL IMPLANT MATERIAL
K943275 · Porex Surgical, Inc. · Sep 1994
STERILE/SINGLE USE EYE SPHERE IMPLANTS
K921106 · Storz Instrument Co. · Mar 1992