STRYKER RESORBABLE FIXATION SYSTEM

K113109 · Stryker · HRS · Dec 23, 2011 · Orthopedic

Device Facts

• Record ID: K113109
• Device Name: STRYKER RESORBABLE FIXATION SYSTEM
• Applicant: Stryker
• Product Code: HRS · Orthopedic
• Decision Date: Dec 23, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Stryker Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.

Device Story

Stryker Resorbable Fixation System is a cranio-maxillofacial plating system used for bone fixation in trauma or reconstruction. Components include resorbable plates, meshes, and screws made of a poly lactide and poly glycolide copolymer. The system is used in clinical settings by surgeons; it is not for mandible or full load-bearing applications. The copolymer degrades in vivo via hydrolysis into lactic and glycolic acid, which are metabolized into water and carbon dioxide. Modifications in this submission include a 0.5 mm low-profile mesh, increased screw thread pitch, and increased thread pitch for standard and self-drilling taps. The device provides mechanical stabilization of bone segments during the healing process.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design and technological similarities to the predicate device.

Technological Characteristics

Resorbable bone fixation system consisting of plates, meshes, and screws. Material: Copolymer of poly lactide and poly glycolide. Degradation mechanism: In vivo hydrolysis. Dimensions: 0.5 mm low-profile mesh, 1.7 mm and 2.2 mm diameter screws (with 2.6 mm emergency option). Features: Color-coded components, modified thread pitch for screws and taps.

Indications for Use

Indicated for fixation of craniofacial and midfacial skeletal bones in adult and pediatric patients following trauma or for reconstruction. Contraindicated for use in the mandible or full load-bearing procedures.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Stryker Leibinger Resorbable Fixation System (K993061)
• Lactosorb 1.5mm Implants – Mesh Panels (K971870)
• Stryker Neuro II 0.3mm Titanium Mesh (K983528)

Submission Summary (Full Text)

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K 113109

Page 1/3

DEC 2 3 2011

Special 510/k)

**stryker**®

Craniomaxillofacial

# 510(k) Summary of Safety and Effectiveness:

## Stryker Resorbable Fixation System

Proprietary Name:

Common Name:

Classification Name and Reference:

Proposed Regulatory Class:

Product Codes:

Predicate Device:

Stryker Resorbable Fixation System

Resorbable Bone Plating System

Sec. 888.3030 - Single/multiple component metallic bone fixation appliance and accessories

Class II

HRS, MAI, EZX, DZJ and HWC

• Stryker Leibinger Resorbable Fixation

System - K993061

• Lactosorb 1.5mm Implants – Mesh Panels

- K971870

· Stryker Neuro II 0.3mm Titanium Mesh

- K983528

Page 8 of 53

750 Trade Centre Way Suite 200 Portage, MI 49002 t: 269 324 5346 f: 877 648 7114 www.stryker.com

Stryker Resorbable Fixation System

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Stryker Resorbable Fixation System

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Special 510(k)

### For Information contact:

Manish Patel Regulatory Compliance Analyst Stryker Craniomaxillofacial 750 Trade Centre Way, Suite 200 Portage, MI 49002 Phone: [phone] [e-mail]

### Date Prepared:

10/18/2011

### Description:

This Special 510(k) is being submitted to the U.S. FDA to provide authorization to market modifications to the Stryker Leibinger Resorbable Fixation System cleared under K993061.

### Proposed Modification:

The subject Stryker Resorbable Fixation System has the same intended use and indications for use, is constructed from the same material, and has the same fundamental scientific technology as the previously cleared Leibinger Resorbable Fixation System under K993061.

The only changes are below

- 1. Addition of a 0.5 mm Low Profile Mesh to an already existing 0.7 mm size range
- 2. Increase in thread pitch of screws
- 3. Increase in thread pitch of standard and self-drilling taps

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K113109 Page 3/3

Stryker Resorbable Fixation System

Special 510(k)

#### Device Description:

The Stryker Delta Resorbable Fixation System is a cranio-maxillofacial plating system, intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in mandible and/or full load bearing procedures. It consists of resorbable bone fixation plates, meshes and screws made of a copolymer of poly lactide and poly glycolide. The copolymer degrades and resorbs in vivo by hydrolysis into lactic and glycolic acid which are metabolized in the body to water (Η₂Ο) and carbon dioxide (CO₂). The Delta Resorbable Fixation System is color coded and currently offered in two diameters, 1.7 mm and 2.2 mm with an emergency screw option of 2.6 mm. As the resorbable bone fixation plates and other devices already cleared in the earlier submission have not been modified, they are not described in this Special 510(k).

### Intended Use / Indications for Use:

The Stryker Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.

.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 2 3 2011

Stryker % Manish Patel Regulatory Compliance Analyst 750 Trace Centre Way, Suite 200 Portage. Michigan 49002

Re: K113109 Trade/Device Name: Stryker Resorbable Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, MAI, EZX, DZJ, HWC Dated: December 2, 2011 Received: December 5, 2011

Dear Manish Patel:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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### Page 2 - Manish Patel

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours

ely yours,
For Mitter
Def. D.K.

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (If known): K113109

Device Name: Stryker Resorbable Fixation System

Indications for Use:

The Stryker Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kurek Mxim
Division Sign Off

Division Sig Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K113109