Cleared Traditional

K110554 - BIOCERAMIC ORBITAL IMPLANT, ORBTEX

K110554 is an FDA 510(k) clearance for BIOCERAMIC ORBITAL IMPLANT, manufactured by Ceramisys, Ltd.. The device is a Class 2 Ophthalmic device with product code HPZ cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K110554 · Ceramisys, Ltd. · Ophthalmic device
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Nov 2011
Decision
247d
Days
Class 2
Risk

K110554 is an FDA 510(k) clearance for the BIOCERAMIC ORBITAL IMPLANT, ORBTEX. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Ceramisys, Ltd. (Centercille, US). The FDA issued a Cleared decision on November 2, 2011 after a review of 247 days - an extended review cycle.

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

FDA 510(k) Submission Details - K110554

510(k) Number K110554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2011
Decision Date November 02, 2011
Days to Decision 247 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 110d · This submission: 247d
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 33
Devices cleared under the same product code (HPZ) and FDA review panel - the closest regulatory comparables to K110554.
EZYPOR
K212741 · Fci (France Chirurgie Instrumentation) Sas · Jun 2022
DURETTE OCULAR IMPLANT
K123764 · Oculo Plastik, Inc. · Jan 2013
SILICONE SPHERES
K112176 · Oculo Plastik, Inc. · Sep 2011
ORBITAL RECONSTRUCTIVE IMPLANT II
K083342 · Evera Medical, Inc. · Mar 2009
EYE SPHERES
K082850 · Product and Educational Services, LLC · Feb 2009
DURETTE IMPLANT
K073293 · Oculo Plastik, Inc. · Mar 2008
K110554 · BIOCERAMIC ORBITAL IMPLANT, ORBTEX
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