CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM

K992905 · Codman & Shurtleff, Inc. · JEY · Aug 1, 2000 · Dental

Device Facts

• Record ID: K992905
• Device Name: CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM
• Applicant: Codman & Shurtleff, Inc.
• Product Code: JEY · Dental
• Decision Date: Aug 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CODMAN® CRANIOSORB™ Absorbable Fixation System is intended for surgical procedures in which internal fixation is required to align and stabilize bony tissue for craniofacial skeletal reconstruction and the repair of traumatic fractures of the craniofacial skeleton.

Device Story

Absorbable fixation system for craniofacial surgery; includes plates, mesh, and rivets in various shapes/sizes. Implanted by surgeons during craniofacial reconstruction or fracture repair to align/stabilize bone. Material composition: blend of poly(D,L-Lactide), polycaprolactone, and polydioxanone for plates/mesh; poly L-lactic acid (PLLA) for rivets. Device provides temporary mechanical stabilization of bony tissue while undergoing absorption. Benefits include elimination of permanent hardware and associated long-term complications.

Clinical Evidence

Bench testing only. Five performance studies conducted: retained strength over time, dimensional stability, simulated bend testing, and pullout/push-out testing. Biocompatibility testing performed on polymer blend, including cytotoxicity, sensitization, and tissue reaction implant studies.

Technological Characteristics

Absorbable fixation system. Materials: poly(D,L-Lactide), polycaprolactone, and polydioxanone (plates/mesh); poly L-lactic acid (PLLA) (rivets). Mechanical fixation principle. Non-electronic, non-software device.

Indications for Use

Indicated for surgical internal fixation to align and stabilize bony tissue for craniofacial skeletal reconstruction and repair of traumatic craniofacial fractures. Contraindicated for use in the mandible and as primary fixation in weight-bearing areas.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

• LactoSorb® Trauma Plating System (K971870)
• MacroPore Protective Sheet (K972913)

Submission Summary (Full Text)

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#### 1 2000 AUG

# 510(k) Summary for the CODMAN® CRANIOSORB™ Absorbable Fixation System

# Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350

### Contact Person

James M. Flaherty, Ir., RAC Regulatory Affairs Specialist Telephone Number. [phone] Fax Number: [phone]

## Name of Device

| Proprietary Name: | CODMAN® CRANIOSORB™ Absorbable Fixation System |
|----------------------|------------------------------------------------------------|
| Common Name: | Craniofacial absorbable fixation system |
| Classification Name: | Cranioplasty plates, plate fasteners, and burr hole covers |

### Device Classification

These devices have been placed in Class II for preformed alterable cranioplasty plates per 21 CFR § 882.5320 (84GWO), for cranioplasty plate fasteners per 21 CFR § 882.5360 (84HBW), and for burr hole covers per 21 CFR § 888.5250 (84GXR).

## Statement of Substantial Equivalence

The CODMAN® CRANIOSORB™ Absorbable Fixation System is substantially equivalent to both the LactoSorb® Trauma Plating System (K971870) and the MacroPore Protective Sheet (K972913) based on the subject device's similarity to the predicate devices in intended use, materials, design, and principles of operation.

## Indications for Use

The CODMAN® CRANIOSORB™ Absorbable Fixation System is intended for surgical procedures in which internal fixation is required to align and stabilize bony tissue for craniofacial skeletal reconstruction and the repair of traumatic fractures of the craniofacial skeleton.

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## Physical Description_

The CODMAN® CRANIOSORB™ Absorbable Fixation System consists of The CODMAN® Clearn of craniofacial reconstruction. The Imm thick plates, mesit, and rivers to be esseesined in various shapes and sizes typical of other marketed fixation devices. The biocompatible implant material used to manufacture the plates and mesh is a blend of poly(D,L-Lactide), polycaprolactone, and polydioxanone. The rivets are constructed of poly L-lactic acid (PLLA).

## Device Testing

Five (5) different performance tests were conducted on the CODMAN® CRANIOSORBTM Absorbable Fixation System in order to assess device suitability for its intended use. These studies evaluated retained strength over time, dimensional stability, simulated bend testing and pullout/push out testing. In addition, biocompatibility testing was performed on the polymer blend used to manufacture the CRANIOSORB™ Plates and Mesh including cytotoxicity, manufacture the organization, and implant studies of tissue reaction

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 1 2000 AUG

Mr. James M. Flaherty, Jr. Regulatory Affairs Specialist Codman & Shurtleff, Incorporated 325 Paramount Drive 02767-0350 Raynham, Massachusetts

K992905 Re : Codman Craniosorb Absorbable Fixation System Trade Name: II Requlatory Class: JEY Product Code: May 2, 2000 Dated: May 3, 2000 Received:

#### Dear Mr. Flaherty:

We have reviewed your Section 510(k) notification of intent to we have reviewed your Becord above and we have determined the market the device references as a substations for device in Babbeanonal psure) to legally marketed predicate use stated in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the enacement aco been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls concisions of the Act include requirements for annual provisions of the hos affectives, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major be subject to back addroid device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set the current Souality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug chrough periodio go mill verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ents respense or ligation you might have under sections 531 noc arrect any obligation for devices under the Electronic enrough Siz or cho notrol provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Flaherty

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for guestions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known) Device Name

# CODMAN® CRANIOSORB™ Absorbable Fixation System

Indications For Use:

The CODMAN® CRANIOSORB™ Absorbable Fixation System is intended for surgical procedures in which internal fixation is required to align and stabilize bony tissue for craniofacial skeletal reconstruction and the repair of traumatic fractures of the craniofacial skeleton.

The CODMAN® CRANIOSORB™ Absorbable Fixation System is contraindicated for use in the mandible and as a primary source of fixation in weight bearing areas.

(Please do not write below this line - Continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumm

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510 Number _______________________________________________________________________________________________________________________________________________________________________

Prescription Use V (Per 21 CFR §801.109)

OR

Over-the-Counter Use

(Optional Format 1-2-96)