SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM

K062789 · Synthes (Usa) · JEY · Feb 27, 2007 · Dental

Device Facts

• Record ID: K062789
• Device Name: SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Feb 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Synthes (USA) Rapid Resorbable Fixation System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, sheets, screws and tacks may be used in non-load bearing applications for maintaining the relative position of, and /or containing, bony fragments, bone grafts, (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.

Device Story

Synthes Rapid Resorbable Fixation System comprises plates, meshes, sheets, screws, and tacks for craniofacial bone alignment and stabilization. Implants are thermoplastic, allowing heating above 55°C or cutting for anatomical contouring. Used by surgeons in clinical settings for fracture repair and reconstruction. Provides non-load bearing fixation for bone fragments and grafts. Benefits include resorbable material, eliminating need for secondary removal surgery. System is not for spinal use or load-bearing areas without supplemental rigid fixation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Material: Poly (L-lactide-co-glycolide). Thermoplastic properties allow shaping via heating above 55°C glass transition temperature or cutting. Components include plates, meshes, sheets, screws, and tacks. Non-electronic, mechanical fixation system.

Indications for Use

Indicated for fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. Non-load bearing applications include maintaining position of bony fragments, bone grafts, or bone graft substitutes in craniofacial or mandibular reconstruction. Contraindicated in load-bearing applications (e.g., mandible) unless used with traditional rigid fixation, areas with active/latent infection, patients with limited blood supply, insufficient bone quality/quantity, or spinal use.

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

• Synthes (USA) Rapid Resorbable Tack System
• Synthes (USA) Poly (L-Lactide-co-Glycolide) Resorbable Fixation System
• Synthes (USA) Rapid Resorbable Cranial Clamp
• Biomet, Inc., Lactosorb Trauma Plating System

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A small "®" symbol is located to the upper right of the word "SYNTHES", indicating that it is a registered trademark.

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Kob2789

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| SPONSOR: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19308<br>[phone] | FEB 27 2007 |
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| DEVICE NAME: | Synthes (USA) Rapid Resorbable Fixation System | |
| CLASSIFICATION: | Class II, §872.4760 - Bone Plate<br>Class II, §888.3030 - Screw Fixation, Intraosseous<br>Class II, §882.5360 - Cranioplasty plate fastener | |
| PREDICATE DEVICE: | Synthes (USA) Rapid Resorbable Tack System<br>Synthes (USA) Poly (L-Lactide-co-Glycolide) Resorbable Fixation System<br>Synthes (USA) Rapid Resorbable Cranial Clamp<br>Biomet, Inc., Lactosorb Trauma Plating System | |
| DEVICE DESCRIPTION: | The Synthes Rapid Resorbable Fixation System consists of Plates, Meshes,<br>Sheets, Screws and Tacks. The system is provided in a variety of shapes<br>and sizes and, when used in conjunction with resorbable screws, the system<br>provides fixation and aids in the alignment and stabilization of craniofacial<br>bones. To facilitate shaping to the contours of the anatomy, the<br>thermoplastic implants may be heated above the glass transition<br>temperature of 55°C or they may be cut to the desired shape. | |
| INTENDED USE: | The Synthes (USA) Rapid Resorbable Fixation System is intended for use<br>in fracture repair and reconstructive procedures of the craniofacial skeleton<br>in pediatric and adult populations. In addition, resorbable meshes, sheets,<br>screws and tacks may be used in non-load bearing applications for<br>maintaining the relative position of, and /or containing, bony fragments,<br>bone grafts, (autograft or allograft), or bone graft substitutes in<br>reconstruction of the craniofacial or mandibular areas. | |
| CONTRAINDICATIONS: | These devices are not intended for use in load bearing applications, such as<br>the mandible, unless used in conjunction with traditional rigid fixation. The<br>Synthes Rapid Resorbable System is not intended for areas with active or<br>latent infection or for patient conditions including limited blood supply or<br>insufficient quantity or quality of bone. These devices are not intended for<br>use in the spine. | |
| SUBSTANTIAL<br>EQUIVALENCE | Comparative information presented supports substantial equivalence. | |
| MATERIAL: | Poly (L-lactide-co-glycolide) | |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeffrey L. Dow Director, Regulatory Affairs Synthes (USA) 1230 Wilson Drive West Chester, Pennsylvania 19380

FEB 2 7 2007

Re: K062789

Trade/Device Name: Synthes (USA) Rapid Resorbable Fixation System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 2, 2007 Received: February 5, 2007

Dear Mr. Dow:

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. Dow

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,

Susan Rumer

~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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## 2.0 Indications for Use Statement

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## Kob2789 510(k) Number (if known):

Device Name:

Indications:

The Synthes (USA) Rapid Resorbable Fixation System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, sheets, screws and tacks may be used in non-load bearing applications for maintaining the relative position of, and /or containing, bony fragments, bone grafts, (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.

Contraindications:

These devices are not intended for use in load bearing applications, such as the mandible, unless used in conjunction with traditional rigid fixation. The Synthes Rapid Resorbable System is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <b>X</b> | OR | Over-The-Counter Use __________ |
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Anesthesiology General Hospital
mi Control, Dansa, Devices
K060789
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