F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE

K072432 · Hand Biomechanics Lab, Inc. · JEC · Jan 9, 2008 · Orthopedic

Device Facts

• Record ID: K072432
• Device Name: F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
• Applicant: Hand Biomechanics Lab, Inc.
• Product Code: JEC · Orthopedic
• Decision Date: Jan 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The F3 Fractured Finger Fixator is indicated for the treatment of acute, unstable dorsal fracturedislocations of the proximal interphalangeal (PIP) joint of the fingers in which external skeletal fixation as provided by the F3 Fractured Finger Fixator alone is sufficient to obtain and maintain concentric reduction of the fracture-dislocation during bone and soft tissue healing.

Device Story

F3 Fractured Finger Fixator is an external skeletal fixator for unstable dorsal PIP joint fracture-dislocations. System includes a pin placement guide, transverse bone pin, dorsal bone pin, and elastic bands. Surgeon inserts pins into the finger; device links pins via elastic bands to exert volarly translating force, maintaining concentric joint reduction while allowing active flexion and extension. Tension adjust screw allows fine-tuning of reduction force. Used in clinical settings by surgeons. Benefits include restored joint alignment and stability during bone/soft tissue healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

External skeletal fixator composed of metal and plastic. Bone pins fabricated from 316L stainless steel (ASTM F138). Includes latex or non-latex elastic bands. Single-use. Sterile or non-sterile delivery.

Indications for Use

Indicated for patients with acute, unstable dorsal fracture-dislocations of the proximal interphalangeal (PIP) joint of the fingers requiring external skeletal fixation for concentric reduction during healing.

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

• Compass PIP Joint Hinge (K970713)

Submission Summary (Full Text)

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## K072432 (pg 1/1)

Image /page/0/Picture/1 description: The image shows a logo for the Hand Biomechanics Lab. On the left side of the logo is a black hand with a curved line above it. To the right of the hand is the text "Hand Biomechanics Lab" in a simple, sans-serif font. The text is stacked vertically, with "Hand" on top, "Biomechanics" in the middle, and "Lab" on the bottom.

### 510(k) Summary

| Owner Information: | Hand Biomechanics Lab, Inc.<br>77 Scripps Drive, Suite 104<br>Sacramento, CA 95825-6209<br>Telephone: [phone]<br>Facsimile: [phone]<br>Contact Person: Jeff Woodhouse<br>Email: [e-mail] | | |
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| Date Prepared: | December 31, 2007 | JAN - 9 2008 | |
| Name of Device: | Trade Name: F3 Fractured Finger Fixator<br>Common Name: External Fixator System<br>Classification Name: Component, Traction, Invasive [21CFR 888.3040,<br>Product Code JEC] | | |

#### Predicate Device: Compass PIP Joint Hinge (Smith & Nephew, Inc. Orthopedic Div.), K970713

### Description of Device:

The F3 Fractured Finger Fixator is an external skeletal fixator designed to obtain and maintain concentric reduction of an unstable dorsal fracture-dislocation of the proximal interphalangeal (PIP) joint. This device exerts a volarly translating force on the middle phalanx while simultaneously lifting the distal end of the proximal phalanx to restore joint alignment. With the dorsal dislocation of the middle phalanx reduced, the fractured fragments of the joint surface are reopposed. The effect of the F3 is present throughout the complete range of finger motion allowing full active flexion and extension during healing of the bone and soft tissues.

Included with the F3 is a custom designed Pin Placement Guide that allows for a Transverse Bone Pin to be accurately placed through the axis of PIP joint rotation. The Dorsal Bone Pin inserted vertically into the middle phalanx. The F3 device is installed on the Dorsal Bone Pin and is linked to the Transverse Bone Pin with Elastic Bands. These bands provide the translating force that holds the joint concentrically reduced. A Tension Adjust Screw on the F3 allows the surgeon to "fine frune" the amount of tension in the Elastic Bands so they exert the least amount of tension necessary to me ' tain joint alignment.

The F3 Fractured Finger Fixator is manufactured using metal and plastic. The bone pins are fabricated from 316L stainless steel per ASTM F138. Both latex and non-latex elastic bands are supplied with the device. All components are designed for single use only.

### Intended Use:

The F3 Fractured Finger Fixator is indicated for the treatment of acute, unstable dorsal fracturedislocations of the proximal interphalangeal (PIP) joint of the fingers in which external skeletal fixation as provided by the F3 Fractured Finger Fixator alone is sufficient to obtain and maintain concentric reduction of the fracture-dislocation during bone and soft tissue healing.

### Technological Characteristics Compared to Predicate Device:

The F3 is comparable to the predicate device with respect to function and application technique. Both are indicated for unstable dorsal fracture-dislocations of the PPP joint and are attached to the finger using bone pins. The F3 uses elastic bands to apply reduction forces across the IP joint, whereas the predicate device uses a distraction screw to apply traction and an engageable worl; gear to control flexion-extension of the PIP joint. The F3 and predicate device are both made of plastic and metal components. The F3 is delivered to the customer in either sterile or non-sterile form. In the non-sterile model, the customer is responsible for sterilization before use. The predicate device is supplied sterile.

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Image /page/1/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with outstretched wings, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings.

Public Health Service

JAN - 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hand Biomechanics Lab., Inc. % Mr. Jeff Woodhouse 77 Scripps Drive Suite 104 Sacramento, CA 95825-6209

Re: K072432 Trade/Device Name: F3 Fractured Finger Fixator Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JEC Dated: January 2, 2008 Received: January 3, 2008

Dear Mr. Woodhouse:

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.

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.

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Page 2 - Mr. Jeff Woodhouse

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

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

Enclosure

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K072432 Cpg 1/1)

# Indications for Use

510(k) Number (if known): K072432

Device Name: F3 Fractured Finger Fixator

Indications for Use:

The F3 Fractured Finger Fixator is indicated for the treatment of acute, unstable dorsal fracture-dislocations of the proximal interphalangeal (PIP) joint of the fingers in which external skeletal fixation as provided by the F3 Fractured Finger Fixator alone is sufficient to obtain and maintain concentrio reduction of the fracturedislocation during bone and soft tissue healing.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

(Division Sign-Off)
Division of GeConcurrence of CDRH, Office of Device Evaluation (ODE

H, Office of Device Evaluation (ODE) Division o and Neurological Devices

**510(k) Number** K072432