PERMAMESH-D HYDROXYLAPATITE MATRIX

• K Number: K960354
• Device Name: PERMAMESH-D HYDROXYLAPATITE MATRIX
• Manufacturer: CERAMED CORP.
• Date Cleared: 1996-03-20 ( 55 days)
• Product Code: LZK
• Regulation Number: 878.3550

Intended Use

Facial (malar) restoration and augmentation,

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.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the material composition and physical form of the implant, with no mention of software, algorithms, or AI/ML terms.

Therapeutic

Yes
The device is described as "Facial (malar) restoration and augmentation," indicating it is used to treat or restore a bodily function or structure, which aligns with the definition of a therapeutic device.

Diagnostic

No

Explanation: The device is described as a "synthetic form of hydroxylapatite...produced in the form of a woven sheet" used for "Facial (malar) restoration and augmentation." This indicates a therapeutic or reconstructive purpose, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "synthetic form of hydroxylapatite... produced in the form of a woven sheet," indicating it is a physical implant, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "Facial (malar) restoration and augmentation." This describes a surgical procedure performed directly on a patient's body for structural support and enhancement.
• Device Description: The device is a "synthetic form of hydroxylapatite... produced in the form of a woven sheet." This is a physical implant material.
• Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status. The description of PermaMesh-D does not involve any such testing of specimens.

Therefore, PermaMesh-D is a surgical implant, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Facial (malar) restoration and augmentation

Product codes

Not Found

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

malar

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

Not Found

Regulation Number and Section

§ 878.3550 Chin prosthesis.

(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.

Summary

0

K960354
1 of 1

510(k) SUMMARY

January 22, 1996

MAR 2 0 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.