PERMAMESH-D HYDROXYLAPATITE MATRIX

K960354 · Ceramed Corp. · LZK · Mar 20, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960354
• Device Name: PERMAMESH-D HYDROXYLAPATITE MATRIX
• Applicant: Ceramed Corp.
• Product Code: LZK · General, Plastic Surgery
• Decision Date: Mar 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3550
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Indications for Use

Indicated for patients requiring facial (malar) 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

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
[phone]
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.