Cleared Traditional

K021357 - MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT

K021357 is an FDA 510(k) clearance for MEDPOR PLUS ORBITAL VOLUME REPLACEMENT ..., manufactured by Porex Surgical, Inc.. The device is a Class 2 Ophthalmic device with product code HPZ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K021357 · Porex Surgical, Inc. · Ophthalmic device
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Aug 2002
Decision
98d
Days
Class 2
Risk

K021357 is an FDA 510(k) clearance for the MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Porex Surgical, Inc. (Newnan, US). The FDA issued a Cleared decision on August 5, 2002 after a review of 98 days - within the typical 510(k) review window.

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.

View all Porex Surgical, Inc. devices

FDA 510(k) Submission Details - K021357

510(k) Number K021357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2002
Decision Date August 05, 2002
Days to Decision 98 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 110d · This submission: 98d
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 21
Devices cleared under the same product code (HPZ) and FDA review panel - the closest regulatory comparables to K021357.
ORBITAL RECONSTRUCTIVE IMPLANT
K070130 · Becker & Associates Consulting, Inc. · Apr 2007
ALPHASPHERE ORBITAL IMPLANT
K053298 · Hydron Pty Limited · May 2006
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
K040851 · Porex Surgical, Inc. · Jul 2004
MEDPOR QUAD MOTILITY IMPLANT
K010902 · Porex Surgical, Inc. · Jun 2001
BIOCERAMIC ORBITAL IMPLANT
K992294 · Fci Ophthalmics, Inc. · Apr 2000
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER
K982562 · Integrated Orbital Implants, Inc. · Dec 1998