SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM

K030069 · Synthes (Usa) · JEY · Apr 8, 2003 · Dental

Device Facts

• Record ID: K030069
• Device Name: SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Apr 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System devices (Plates, Meshes, Sheets and Screws) are intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. In addition, Resorbable Meshes, Sheets and Screws 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

Resorbable fixation system consisting of plates, meshes, sheets, and screws; used for stabilization and alignment of craniofacial bones. Implants are thermoplastic; can be heated above 55°C or cut to contour to patient anatomy. Used by surgeons in clinical settings for fracture repair and reconstruction. Provides temporary fixation; aids in maintaining position of bone fragments or grafts. Benefits patient by providing structural support during healing without requiring secondary removal surgery due to resorbable material properties.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and material characterization.

Technological Characteristics

Resorbable fixation system composed of Poly (L-Lactide-co-Glycolide). Thermoplastic material; glass transition temperature of 55°C. Includes plates, meshes, sheets, and screws in various shapes and sizes. Non-load bearing design. Manual shaping via heating or cutting.

Indications for Use

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

• Lorenz LactoSorb® Trauma Plating System (Biomet)
• Synthes Resorbable Fixation System, Poly (L/DL-lactide)

Submission Summary (Full Text)

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APR 0 8 2003

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## K030069

| 2. 510(k) Summary | Page 1 of 1 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Synthes (USA) 1690 Russell Road, Paoli, PA 19301 |
| Company Contact: | Bonnie J. Smith<br>[phone] |
| Name of Device: | Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System |
| Device Classification /<br>Common Name: | Class II, 21 CFR §872.4760 - Bone Plate<br>Class II, 21 CFR §888.3030 - Screw Fixation, Intraosseous |
| Predicate Device: | Lorenz LactoSorb® Trauma Plating System (Biomet) and Synthes<br>Resorbable Fixation System, Poly (L/DL-lactide) |
| Intended Use: | Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System<br>devices (Plates, Meshes, Sheets and Screws) are intended for use in<br>fracture repair and reconstructive procedures of the craniofacial skeleton.<br>In addition, Resorbable Meshes, Sheets and Screws may be used in non-<br>load bearing applications for maintaining the relative position of and/or<br>containing bony fragments, bone grafts (autograft or allograft) or bone<br>graft substitutes in reconstruction of the craniofacial or mandibular areas. |
| Contraindications: | These devices are not intended for use in full load bearing applications,<br>such as the mandible, unless used in conjunction with traditional rigid<br>fixation. Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation<br>System devices are not intended for areas with active or latent infection or<br>for patient conditions including limited blood supply or insufficient<br>quantity or quality of bone. These devices are not intended for use in the<br>spine. |
| Device Description: | Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System<br>consists of Plates, Meshes, Sheets and Screws. The system is provided in a<br>variety of shapes and sizes and, when used in conjunction with resorbable<br>screws, the system provides fixation and aids in the alignment and<br>stabilization of craniofacial bones. To facilitate shaping to the contours of<br>the anatomy, the thermoplastic implants may be heated above the glass<br>transition temperature of 55° C or they may be cut to the desired shape. |

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APR 0 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K030069

Trade/Device Name: Sythes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: January 6, 2003 Received: January 8, 2003

Dear Ms. Smith:

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 - Ms. Smith

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/dsma/dsmamain.html

Sincerely yours.

Susan Roane

Susan Runner, DDS, MA Interim 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. Indications for Use Statement

| | Page 1 of 1 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K030069 |
| DEVICE NAME: | Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System |
| INDICATIONS: | Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation<br>System devices (Plates, Meshes, Sheets, and Screws) are<br>intended for use in fracture repair and reconstructive procedures<br>of the craniofacial skeleton. In addition, Resorbable Meshes,<br>Sheets and Screws may be used in non-load bearing applications<br>for maintaining the relative position of and/or containing bony<br>fragments, bone grafts (autograft or allograft) or bone graft<br>substitutes in reconstruction of the craniofacial or mandibular<br>areas. |
| CONTRAINDICATIONS: | These devices are not intended for use in full load bearing<br>applications, such as the mandible, unless used in conjunction<br>with traditional rigid fixation. Synthes Poly (L-Lactide-co-<br>Glycolide) Resorbable Fixation System devices are not intended<br>for areas with active or latent infection or for patient conditions<br>including limited blood supply or insufficient quantity or quality<br>of bone. These devices are not intended for use in the spine. |
| | (PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON<br>ANOTHER PAGE IF NEEDED) |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;">OR</div> | Over-the-Counter Use |
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| Synthes (USA)<br>Premarket Notification 510(k)<br>PLLA/PGA Resorbable Fixation System | CONFIDENTIAL | <div> <span style="text-decoration: overline;">Ren Muly</span> </div> (Division Sign-Off) for MSA <div>Division of Anesthesiology, General Hospital,</div> <div>Infection Control, Dental Devices</div> <div>510(k) Number: <span style="text-decoration: underline;">K030069</span></div> |
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