← Product Code [FWP](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP) · K960349

# PERMARIDGE HYDROXYLAPATITE MATRIX (K960349)

_Ceramed Corp. · FWP · Mar 13, 1996 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K960349

## Device Facts

- **Applicant:** Ceramed Corp.
- **Product Code:** [FWP](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP.md)
- **Decision Date:** Mar 13, 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 restoration and augmentation.

## Device Story

Synthetic hydroxylapatite (HA) implant; woven sheet form. Input: high-purity, radiopaque, 1000-micron rounded HA particles. Transformation: particles organized into flexible, cloth-like matrix using absorbable suture. Output: implantable material for facial restoration/augmentation. Used by surgeons in clinical settings. Provides structural support for facial tissue; biocompatible mineral scaffold.

## Clinical Evidence

Bench testing only. Material characterization via X-ray diffraction confirms 100% HA composition. Compliance with ASTM F1185 for trace elements and calcium-to-phosphorus ratio (1.69) verified.

## Technological Characteristics

Material: 100% synthetic hydroxylapatite (HA) beads. Standards: ASTM F1185 (composition/trace elements). Geometry: 1000-micron diameter particles. Form: Woven sheet/cloth-like matrix via absorbable suture. Radiopaque. Non-resorbable ceramic component.

## 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
- OsteoGraf/D-700 (Originally OsteoGraf/AR)

## Submission Summary (Full Text)

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# 510(k) SUMMARY

January 22, 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:**
PermaRidge Hydroxylapatite Matrix, 1000 microns
Classification Name: Chin implant

3.  **Predicate Device:**
MEDPOR® Surgical Implant
OsteoGraf/D-700 (Originally OsteoGraf/AR)

4.  **Device Description:**
PermaRidge 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 restoration and augmentation.

6.  **Comparison of Product Characteristics:**
PermaRidge consists of 100% synthetic hydroxylapatite beads strung on absorbable suture.

X-ray diffraction shows PermaRidge beads to be 100% HA. The hydroxylapatite component of PermaRidge 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/FWP/K960349](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K960349)

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