PERMARIDGE HYDROXYLAPATITE MATRIX

K960349 · Ceramed Corp. · FWP · Mar 13, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960349
• Device Name: PERMARIDGE HYDROXYLAPATITE MATRIX
• Applicant: Ceramed Corp.
• Product Code: FWP · General, Plastic Surgery
• Decision Date: Mar 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3550
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Indications for Use

Indicated for patients requiring facial restoration and augmentation.

Regulatory Classification

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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K960349
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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
[phone]
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.