SYNTHES (USA) RESORBABLE FIXATION SYSTEM

K021928 · Synthes (Usa) · JEY · Sep 6, 2002 · Dental

Device Facts

• Record ID: K021928
• Device Name: SYNTHES (USA) RESORBABLE FIXATION SYSTEM
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Sep 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Resorbable Fixation System devices (Plates, Meshes, Screws and Tacks), are intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. In addition, Resorbable Meshes, 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 Resorbable Fixation System comprises resorbable plates, meshes, screws, and tacks; manufactured from 70:30 poly(L/DL-lactide). Used by surgeons in craniofacial fracture repair and reconstruction; stabilizes bony fragments or bone grafts. Non-load bearing applications only; may be used alone or with metallic internal fixation. Provided sterile via gamma radiation; single-use. Benefits include temporary stabilization of bone segments during healing without requiring secondary removal surgery due to resorbable material properties.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and material properties.

Technological Characteristics

Materials: 70:30 poly(L/DL-lactide). Components: Plates, meshes, screws, tacks. Sterilization: Gamma radiation. Form factor: Various sizes for craniofacial application. Non-load bearing design.

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 substitutes in craniofacial/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, 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 Resorbable Fixation System
• Synthes Resorbable Tack System
• Synthes Resorbable Meshes and Sheets

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized bird or a series of interconnected human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 2003

Ms. Angela Silvestri Synthes USA 1690 Russell Road Post Office Box1766 Paoli. Pennsylvania 19301

Re: K021928

Trade/Device Name: Synthes Resorbable Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: December 11, 2002 Received: December 12, 2002

Dear Ms. Silvestri:

This letter corrects our substantially equivalent letter of September 6, 2002, regarding the Synthes Resorbable Fixation System. FDA had erred in originally clearing K021828 for market in 2002. At that time the second statement in your second Indications for Use Statement for this system should not have been cleared as a dental indication for use for the following reasons:

- 1. This second statement in your Indication for Use should have been submitted to the Orthopedics Branch of the Office of Device Evaluation for review. If you wish to make this claim, please submit a new premarket notification to the Orthopedics Branch of ODE for this indication for use.
- 2. The second statement in your Indication for Use Statement states that the device may be used for soft tissue prolapse in the iliac crest. This indication for use has not been previously cleared for devices used in the maxillofacial region.
- 3. Your second Indication for Use statement is contradictory to the contraindication mentioned in the second paragraph of that same Indications for Use Statement because the ilium is considered to be load bearing. This bone is an integral part of the pelvic girdle that supports loads from the thorax, arms, neck, and head.

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## Page 2 - Ms. Silvestri

We have reviewed vour revised 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 (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 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.

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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone].

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Page 3 - Ms. Silvestri

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Timothy A. Ulatowski

Timo Ulatowski ay A Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Enclosure

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Image /page/3/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. The circular symbol contains a stylized image of a person. The word "SYNTHES" is in all capital letters, and a registered trademark symbol is located to the right of the "S".

### 1. Indications for Use

| | Page 1 of 1 |
|---------------------------|------------------------------------------|
| 510(k) Number (if known): | K021928 |
| Device Name: | Synthes (USA) Resorbable Fixation System |

Indications

Synthes Resorbable Fixation System devices (Plates, Meshes, Screws and Tacks), are intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton.

In addition, Resorbable Meshes, 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 full load bearing applications, such as the mandible, unless used in conjunction with traditional rigid fixation. Synthes Resorbable Fixation System devices are 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use C (Per 21 CFR 801.109)

OR Over-the-Counter Use

Suren Rumny

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

=10(k) Number: K62 Max

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#### 6 2002 SEP

- 3. 510(k) Summary

| Submitter | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Bonnie Smith<br>[phone] |
| Name of the Device | Synthes (USA) Resorbable Fixation System |
| Predicate Device | Synthes Resorbable Fixation System, Synthes Resorbable Tack System<br>and Synthes Resorbable Meshes and Sheets. |
| Device Description | Synthes Resorbable Fixation System consists of resorbable plates, meshes,<br>screws, tacks and accessory devices. Synthes Resorbable devices are<br>manufactured from 70:30 poly (L/DL-lactide) and are available in various<br>sizes. Resorbable meshes and sheets may be used as indicated, either<br>alone or in conjunction with internal fixation devices (e.g., metallic plates<br>and screws) that serve to further stabilize the treatment area. |
| | Resorbable Fixation System devices are provided pre-sterilized by gamma<br>radiation. They are not intended to be resterilized by the user. |
| Indications for Use | Synthes Resorbable Fixation System devices (Plates, Meshes, Sheets,<br>Screws and Tacks), are intended for use in fracture repair and<br>reconstructive procedures of the craniofacial skeleton. In addition,<br>Resorbable Meshes, Sheets, Screws and Tacks may be used in non-load<br>bearing applications for : |
| | <ul><li>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</li><li>Preventing soft tissue prolapse at bone graft donor sites, e.g., the iliac<br/>crest</li></ul> |
| 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 Resorbable Fixation devices are not intended for areas<br>with active or latent infection or for patient conditions including limited<br>blood supply or insufficient quantity or quality of bone. These devices are<br>not intended for use in the spine. |