ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES

K072528 · Prosurg, Inc. · JEY · Dec 28, 2007 · Dental

Device Facts

• Record ID: K072528
• Device Name: ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES
• Applicant: Prosurg, Inc.
• Product Code: JEY · Dental
• Decision Date: Dec 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and chin in adult and children.

Device Story

System comprises bioabsorbable plates, meshes, screws, fasteners, tacks, tension wires, and anchor pins for craniofacial bone fixation. Used in trauma and reconstructive surgery for adults and children. Components made from poly(L-lactide & DL-lactide) copolymer. Surgeons install plates and meshes using 1.8mm or 2.1mm screws, tacks, or anchor pins; screws tightened via conventional screwdriver or endoscopic device. System provides mechanical stabilization of bone segments during healing; bioabsorbable material eliminates need for secondary removal surgery. Clinical benefit includes stable fixation of craniofacial fractures and osteotomies, facilitating bone healing in pediatric and adult populations.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated tensile strength (2.5 Lb/in2) and breakage pull force (4.0 Lb/in2). Installation pull force using clamp tool with 2.0mm stops measured <1.0 Lb/in2. Degradation time is identical to predicate.

Technological Characteristics

Bioabsorbable co-polymer material: Poly(L-Lactide & DL-Lactide) (70:30 or 85:15). Components: plates, meshes, screws (1.8mm/2.1mm), fasteners, tacks, tension wires, anchor pins. Mechanical fixation via screw/tack deployment. Single-use. Non-electronic.

Indications for Use

Indicated for adults and children requiring trauma or reconstructive procedures of the craniofacial skeleton, mid-face, maxilla, and chin. Specific applications include fractures of the cranium, mid-face, maxilla, and chin; infant craniofacial surgery (e.g., craniosynostosis, congenital malformations); Le Forte (I, II, III) osteotomies; pediatric reconstructive procedures of the craniofacial skeleton; orthognathic procedures; and facial craniotomy flap fixation.

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

• XSorb™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories (K070737)

Submission Summary (Full Text)

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DEC 2 8 2007

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## 510K Summary of Safety & Effectiveness

Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories

Company:

Contact:

Prosurg, Inc 2193 trade Zone blvd San Jose CA 95131

Ashvin Desai , Mgr Regulatory Affairs Tel: [phone]

Date Preparaed: September 4, 2007

Device Name: Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories

Predicated Devices: XSorb™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories

#### Device Description:

Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories consists of single use, bioabsorbable, Self Compression Bone Fixation plates, meshes, fixation screws, fasteners, tacks, tenion wires and anchor pins designed for use in trauma and reconstructive procedures for craniofacial skeleton, mid-face, maxilla and chin in adult and children. The single use, bioabsorbable, self compression, Bone fixation plates are offered in various sizes and configurations to meet anatomical needs of the patients. TheAdjustable Bone Plates™- Bioabsorbable Craniofacial Bone Fixation plates, mesh, screws .tension wires, tacks and anchor pins are made from bioabsorbable co-polymer material of Poly (L -Lactide & DL-Lactide-70:30 or 85:15 ). The bone plates and meshes are designed to be used with 1.8mm and 2.1 mm screws, tacks and anchor pins for trauma and reconstructive procedure. The bioabsorbable screws can be tightened with 1.8mm conventional screw driver or deployed with endoscopic device.

Indications for Use:

#### General Indication for Use:

Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and chin in adult and children.

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K072528

### Specific Indications for Use:

- . Fractures of the cranium, mid-face, maxilla and chin.
- . Infant craniofacial surgery ( i.e. Craniosynostosis, Congenital malformations)
- . Le Forte ( I, II, III ) Osteotomies.
- . Pediatric Reconstructive procedures of Cranial facial Skeleton
- . Orthognathic or Reconstructive procedures of mid-face, maxilla & chin.
- Facial Craniotomy flap fixation. .

### Product Comparision with Predicate Device:

# Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories

#### Comparison of Technological Characteristics:

Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and chin in adult and children is substantially equivalent to the predicated device Xsorb™ Bioabsorbable, Craniofacial Bone Fixation System & Accessories cleared by FDA under 510k application #K070737. The FDA regulatory clearance report, 510k application and product information details regarding predicated device is attached herewith for your review and consideration. Please review the comparison matrix ( Attachment I ) outlining the Product specifications, Material compatibility and Indications for Use for the proposed device with predicated device. Please note that the proposed product is substantially equivalent to predicated devices in product design, materials, packaging and intended use.

#### Performance Testing Data:

Preclinical testing was performed to ensure that the Adjutable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories products performs as intended when used according to the instructions for use. Laboratory product testing has indicated that the Adjustable Bone Plates™- Bioabsorbable Craniofacial Bone Fixation System & Accessories has demonstrated satisfactory performance for its intended applications. Mechanical testing of the devices also demonstrated that the tensile strength, breakage force and degradation time for the device are equivalent to predicated devices & are satisfactory for its intended use. The average tensile strength and breakage Pull force value for Adjustable Bone Plates™ ( X= 2.5 Lb / in2 and 4.0 Lb/ in2 respectively), The average pull force applied during Adjustable Bone plate installation, using Clamp Tool (with 2.0mm pre-set stops) is less than 1.0 Lb/ in2 The actual degradation time of the proposed and predicate device are practically identical. The material selection, manufacturing process, product packaging , sterilization process and indication for use are also identical. Based on the product test data, we have determined that the proposed device, Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories is substantially equivalent to predicate device Xsorb™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories cleared by FDA under 510k application #K070737.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 8 2007

Mr. Ashvin Desai Manager, Regulatory Affairs Prosurg, Incorporated 2195 Trade Zone Boulevard San Jose, California 95131

Re: K072528

Trade/Device Name: Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: December 4, 2007 Received: December 10, 2007

Dear Mr. Desai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Desai

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding 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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Sheela H. Mccaughey, D.O. for Colleen Van Kirk

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K072528

CENTER FOR DEMOGRAPHIC AND POPULATION HEALTH

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# Indications for Use

510(k) Number (if known): K0772528

Device Name: Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories

Indications for Use:

### General Indication for Use:

Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and chin in adult and children.

### Specific Indications for Use:

- Fractures of the cranium, mid-face, maxilla and chin. ●
- Infant craniofacial surgery ( i.e. Craniosynostosis, Congenital malformations) .
- Le Forte ( I, II, III ) Osteotomies. .
- Pediatric Reconstructive procedures of Cranial facial Skeleton.
- Orthognathic or Reconstructive procedures of mid-face, maxilla & chin.
- Facial Craniotomy flap fixation.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

OF NEEDED)
Emily Murphy

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072528