SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061

K092754 · Small Bone Innovations, Inc. · HWC · Jan 19, 2010 · Orthopedic

Device Facts

• Record ID: K092754
• Device Name: SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061
• Applicant: Small Bone Innovations, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jan 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The SBi Foot and Ankle Cannulated Screws and Washers are intended for fixation of small and long bones, such as femoral neck fractures; slipped capitol femoral epiphysis; tibial plateau fractures; ankle arthrodesis; pediatric femur fractures; intercondylar femur fractures; sacroiliac joint disruptions; and subtalar arthrodesis. The system is not intended for spinal use. The implants are intended for single use only.

Device Story

SBi Foot and Ankle Cannulated Screw System provides internal bone fixation. System comprises cannulated screws, washers, guide wires, and implantation instruments. Used by orthopedic surgeons in clinical/OR settings for fracture stabilization and arthrodesis. Implants are non-sterile, single-use, and available in various diameters and thread configurations (fully or partially threaded). Surgeons use guide wires to position screws across bone segments; cannulated design allows over-the-wire placement. Provides mechanical stability to facilitate bone healing. Not for spinal applications.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Implant grade 316LS stainless steel (ASTM F138) and Titanium Alloy (ASTM F136). Design: Cannulated screw system with various lengths, diameters, and thread configurations (fully or partially threaded). Includes matching washers, guide wires, and surgical instruments. Non-sterile supply.

Indications for Use

Indicated for fixation of small and long bones in patients requiring stabilization of fractures or arthrodesis, including femoral neck, tibial plateau, pediatric femur, and intercondylar femur fractures, as well as slipped capitol femoral epiphysis, sacroiliac joint disruptions, and ankle or subtalar arthrodesis. Not for spinal use.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes 6.5mm and 7.0/7.3mm Cannulated Screws (K962011, K021932, K052483)
• Howmedica Osteonics (Stryker) Asnis III 5.0mm, 6.5mm, and 8.0mm Cannulated Screws (K983006, K000080)

Submission Summary (Full Text)

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092754

## 510(k) Premarket Notification Summary of Safety and Effectiveness

## Submission Information

| Manufacturer: | Small Bone Innovations, Inc.<br>1380 South Pennsylvania Avenue<br>Morrisville, PA 19067<br>Ph: 215-428-1791 Fax: [phone] |
|---------------|-------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations, Inc.<br>John Minier<br>1380 South Pennsylvania Avenue<br>Morrisville, PA 19067 |

Proprietary Name: SBi Foot and Ankle Cannulated Screw System

Classification name: Class II, 21 CFR 888.3040 - Screw, Fixation, Bone

Product Code: HWC

Common/Usual Name and Reference Number: Primary: Smooth or threaded metallic bone fixation fastener, 21 CFR 888.3040

Substantial Equivalence: Documentation is provided which demonstrated the SBi Large Cannulated Screw System to be substantially equivalent to other legally marketed devices.

Device Description: The SBi Foot and Ankle Cannulated Screw System consists of screws and washers that provide fixation of small and long bones. The devices are supplied non-sterile and are available in various sizes and configurations. There are several lengths and diameters of the cannulated screws washers appropriate to the screw diameter. There are fully threaded and partially threaded (16mm and 32mm of thread) configurations. The system also includes guide wires and instruments for use in implanting the screws.

Intended Use: The SBi Foot and Ankle Cannulated Screws and Washers are intended for fixation of small and long bones, such as femoral neck fractures; slipped capitol femoral epiphysis; tibial plateau fractures; ankle arthrodesis; pediatric femur fractures; intercondylar femur fractures; sacroiliac joint disruptions; and subtalar arthrodesis. The system is not intended for spinal use.

The implants are intended for single use only.

Materials: The implants are made from implant grade 316LS stainless steel (ASTM F138) in a set with several thread configurations in a range of lengths and will include the appropriate size washers of the same material. Another implant set is made from implant grade Titanium Allov

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(ASTM F136) which will consist of similar thread configurations and range of lengths and will include the appropriate size washers of the same material.

Predicate Devices: The subject devices are equivalent to Synthes 6.5mm and 7.0/7.3mm Cannulated Screws (K962011, K021932, K052483) and Howmedica Osteonics (Stryker) Asnis III 5.0mm, 6.5mm, and 8.0mm Cannulated Screws (K983006, K000080).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Small Bone Innovations, Inc. % Mr. John Minier Regulatory Affairs Director 1380 South Pennsylvania Avenue Morrisville, Pennsylvania 19067

JAN 1 9 2010

Re: K092754

Trade/Device Name: SBi Foot and Ankle Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fasteners Regulatory Class: II Product Code: HWC Dated: December 23, 2009 Received: December 29, 2009

Dear Mr. Minier:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2- Mr. John Minier

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,

Joulan Mucho
for

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

Enclosure

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## 4 Statement of Indications for Use

510(k) Number:

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Device Name: SBi Foot and Ankle Cannulated Screw System

Indications For Use:

The SBi Foot and Ankle Cannulated Screw System is indicated for fixation of small and long bones, such as femoral neck fractures; slipped capitol femoral epiphysis; tibial plateau fractures; ankle arthrodesis; pediatric femur fractures; intercondy|ar femur fractures; sacroillac joint disruptions; and subtalar arthrodesis. The system is not intended for spinal use.

Prescription Use V (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Ouster for MXM

(Division Sign-Onl. Orthopedic, Division of Sure
and Restorative Devices

510(k) Number K092754