← Product Code [LZK](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK) · K960354

# PERMAMESH-D HYDROXYLAPATITE MATRIX (K960354)

_Ceramed Corp. · LZK · Mar 20, 1996 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K960354

## Device Facts

- **Applicant:** Ceramed Corp.
- **Product Code:** [LZK](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK.md)
- **Decision Date:** Mar 20, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3550
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for Use

Facial (malar) restoration and augmentation.

## Device Story

PermaMesh-D is a synthetic hydroxylapatite (HA) implant for malar restoration and augmentation. Device consists of high-purity, radiopaque, 1000-micron diameter HA particles organized into a flexible, woven, cloth-like sheet using absorbable suture. Implanted by surgeons in clinical settings to restore or augment facial bone structure. Provides a biocompatible, mineral-based scaffold for surgical use.

## Clinical Evidence

Bench testing only. Material composition verified via X-ray diffraction; calcium to phosphorus ratio confirmed at 1.69; compliance with ASTM F1185 standards for ceramic hydroxylapatite.

## Technological Characteristics

Synthetic hydroxylapatite (HA) beads; 1000-micron particle size; woven into flexible sheet using absorbable suture. Radiopaque. Material conforms to ASTM F1185 (Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants).

## Regulatory Identification

A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

## Predicate Devices

- MEDPOR® Surgical Implant

## Submission Summary (Full Text)

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K960 354
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510(k) SUMMARY

January 22, 1996
MAR 20 1996

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

1.  Submitter:
CeraMed Corporation
12860 West Cedar Drive
Lakewood, CO 80228
(303) 985-0800
Contact Person: Barbara A. Watson

2.  Device Name:
PermaMesh-D Hydroxylapatite Matrix, 1000 microns
Classification Name: Malar implant

3.  Predicate Device:
MEDPOR® Surgical Implant

4.  Device Description:
PermaMesh-D is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

5.  Intended Use:
Facial (malar) restoration and augmentation.

6.  Comparison of Product Characteristics:
PermaMesh-D consists of 100% synthetic hydroxylapatite beads strung on absorbable suture.

X-ray diffraction shows PermaMesh-D beads to be 100% HA. The hydroxylapatite component of PermaMesh-D conforms to ASTM Standard # F1185, "Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants", for trace elements. Typical calcium to phosphorus mole ratio is 1.69.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K960354](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K960354)

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