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
Indications for 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
(303) 985-0800
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.
