PERMAMESH HYDROXYLAPATITE MATRIX

K960362 · Ceramed Corp. · LZK · Mar 20, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960362
• Device Name: PERMAMESH 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 restoration and augmentation.

Device Story

Synthetic hydroxylapatite (HA) woven sheet; high-purity, radiopaque, 1000-micron rounded HA particles organized into flexible cloth-like form using absorbable suture. Used for facial restoration and augmentation. Implanted by surgeons to provide structural support or contouring in facial areas.

Clinical Evidence

No clinical data provided; equivalence based on material characterization and chemical analysis.

Technological Characteristics

100% synthetic hydroxylapatite beads; 1000-micron particle size; absorbable suture carrier. Material conforms to ASTM F1185 for trace elements; calcium-to-phosphorus mole ratio 1.69. Radiopaque.

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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K960362
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# 510(k) SUMMARY MAR 20 1996

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:**
PermaMesh Hydroxylapatite Matrix, 1000 microns
Classification Name: Malar implant

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

4. **Device Description:**
PermaMesh 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:**
PermaMesh consists of 100% synthetic hydroxylapatite beads strung on absorbable suture.

X-ray diffraction shows PermaMesh beads to be 100% HA. The hydroxylapatite component of PermaMesh 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.