MINI RAIL EXTERNAL FIXATOR SYSTEM

K093550 · Small Bone Innovations, Inc. · KTT · Jan 7, 2010 · Orthopedic

Device Facts

• Record ID: K093550
• Device Name: MINI RAIL EXTERNAL FIXATOR SYSTEM
• Applicant: Small Bone Innovations, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Jan 7, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SBi Mini Rail External Fixation System is intended for fixation, compression, and distraction osteo-genesis of small bones, such as metacarpal and metatarsal. The system also includes the instruments with which to place the pins and assemble the construct. A tray is available for conveying and storing the system. The system is not intended for spinal use. The pins and external connecting components are intended for single use only. The implants are intended for single use only.

Device Story

SBi Mini Rail External Fixation System provides mechanical stabilization for small bone fractures and reconstruction. System comprises stainless steel pins (implant grade 316LS) and external rails/connectors (medical grade aluminum and stainless steel). Includes surgical instruments for pin placement and construct assembly. Supplied non-sterile; intended for single use. Used by surgeons in clinical settings to achieve fixation, compression, or distraction osteogenesis. Benefits patient by providing rigid external support to facilitate bone healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pins: 316LS stainless steel (ASTM F138). External components: medical grade aluminum and stainless steel. Mechanical fixation system consisting of pins, rails, and connectors. Non-sterile supply. No software or electronic components.

Indications for Use

Indicated for external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal. Not for spinal use.

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

• SBi (formerly Fixano) MiniFIX External Fixator (K964094)

Submission Summary (Full Text)

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.. K093550

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## 6. 510(k) Premarket Notification Summary of Safety and Effectiveness

Submission Information Manufacturer: Small Bone Innovations, Inc. 1380 South Pennsylvania Avenue Morrisville, PA 19067 Ph: 215-428-1791 Fax: [phone]

Submitted By: Small Bone Innovations, Inc. John Minier 1380 South Pennsylvania Avenue Morrisville, PA 19067

Proprietary Name: SBi Mini Rail External Fixation System

Classification name: Class II, 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories

Product Code: KTT

Common/Usual Name and Reference Number: appliance, fixation, nail/blade/plate combination, multiple component, 21 CFR 888.3030

Substantial Equivalence: Documentation is provided which demonstrated the SBi Mini Rail External Fixation System to be substantially equivalent to other legally marketed devices.

Device Description: The SBi Mini Rail External Fixation System consists of pins of various diameters and lengths as well as the rails and accessories with which to connect and stabilize them. The system also includes instruments to implant the pins and connect the external components. A tray is included to store and transport the set. The devices are supplied non-sterile.

Intended Use: The SBi Mini Rail External Fixation System is intended for fixation, compression, and distraction osteo-genesis of small bones, such as metacarpal and metatarsal. The system also includes the instruments with which to place the pins and assemble the construct. A tray is available for conveying and storing the system. The system is not intended for spinal use.

The pins and external connecting components are intended for single use only. The implants are intended for single use only.

Materials: The pins are made from implant grade 316LS stainless steel (ASTM F138). The external components are made from medical grade aluminum and stainless steel.

Predicate Devices: The modified device is equivalent to the cleared SBi (formerly Fixano) MiniFIX External Fixator K964094.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

Re: K093550

Trade/Device Name: SBi Mini Rail External Fixator System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: Class II Product Code: KTT Dated: December 10, 2009 Received: December 11, 2009

JAN - 7 2010

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

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Page 2 - Mr. John Minier

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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Oerbeie Buelup
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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## 6093550 5. Statement of Indications for Use

510(k) Number:

Device Name: SBi Mini Rail External Fixation System

Indications For Use:

The SBi Mini Rail External Fixation System is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.

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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Senatur for mxn

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K093550