Cleared Traditional

K023400 - FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT

K023400 is an FDA 510(k) clearance for FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT, manufactured by Fci Ophthalmics, Inc.. The device is a Class 2 Ophthalmic device with product code HPZ cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K023400 · Fci Ophthalmics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
317d
Days
Class 2
Risk

K023400 is an FDA 510(k) clearance for the FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Fci Ophthalmics, Inc. (Centercille, US). The FDA issued a Cleared decision on August 22, 2003 after a review of 317 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 Fci Ophthalmics, Inc. devices

FDA 510(k) Submission Details - K023400

510(k) Number K023400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2002
Decision Date August 22, 2003
Days to Decision 317 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 110d · This submission: 317d
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 12
Devices cleared under the same product code (HPZ) and FDA review panel - the closest regulatory comparables to K023400.
EZYPOR
K212741 · Fci (France Chirurgie Instrumentation) Sas · Jun 2022
MEDPOR ATTRACTOR IMPLANT
K071335 · Porex Surgical, Inc. · Aug 2007
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
K040851 · Porex Surgical, Inc. · Jul 2004
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
K021357 · Porex Surgical, Inc. · Aug 2002
MEDPOR QUAD MOTILITY IMPLANT
K010902 · Porex Surgical, Inc. · Jun 2001
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER
K982562 · Integrated Orbital Implants, Inc. · Dec 1998