S.E.A.L. FRACTURE FUSION TUBE

K140158 · Dne, LLC · KTT · May 29, 2014 · Orthopedic

Device Facts

• Record ID: K140158
• Device Name: S.E.A.L. FRACTURE FUSION TUBE
• Applicant: Dne, LLC
• Product Code: KTT · Orthopedic
• Decision Date: May 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The S.E.A.L. Fracture Fusion Tube is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.

Device Story

S.E.A.L. Fracture Fusion Tube is an external fixation system for small bone fractures and reconstruction. Device features articulating pin clamps allowing adjustment across three axes and linear translation; enables multi-planar pin placement for frame construction around hand or foot fractures. System facilitates controlled compression/distraction and early weight-bearing. Used by surgeons in clinical settings to stabilize metacarpal and metatarsal fractures, including comminuted intra-articular fractures and arthrodesis. Provides mechanical stabilization to promote bone healing.

Clinical Evidence

No clinical studies were performed. Evidence is based on non-clinical bench testing per ASTM F1541-02 Annex 7.

Technological Characteristics

Materials: 6061-T6 Aluminum, 316L Stainless steel, PTFE, PEEK. Mechanical fixation system with articulating pin clamps for multi-planar adjustment and linear translation. Testing performed per ASTM F1541-02 Annex 7.

Indications for Use

Indicated for external fixation of fractures and reconstruction of small bones, specifically metacarpal and metatarsal bones, including open/comminuted fractures, fractures with length discrepancies, fusions, and corrective osteotomies.

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 Mini Rail External Fixation System (K093550)
• Vilex Rail Fixation System (K052196)
• DFS MiniFixator (K951357/K970290)
• Tomahawk Mini Fixator (K052005)

Submission Summary (Full Text)

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#### K140158

#### 510(k) Summary for the S.E.A.L. Fracture Fusion Tube

MAY 2 9 2014

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the S.E.A.L. Fracture Fusion Tube.

#### 1. GENERAL INFORMATION

| | Date Prepared: January 15, 2014 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Trade Name: S.E.A.L. Fracture Fusion Tube |
| | Common Name: External Fixation Frame |
| | Classification Name: Single/multiple component metallic bone fixation appliances and accessories. |
| Class: | II |
| Product Code: | KTT |
| | CFR section: 21 CFR section 888.3030 |
| Device panel: | Orthopedic |
| Legally Marketed | SBi Mini Rail External Fixation System (Small Bone Innovations, Inc., K093550) |
| Predicate Devices: | Vilex Rail Fixation System (Vilex eX-Fix, K052196)<br>DFS ® MiniFixator (EBI (Biomet), K951357/K970290)<br>Tomahawk Mini Fixator (Wright Medical, K052005) |
| Submitter: | DNE, LLC<br>2225 Park Place<br>Slatington, PA 18080<br>(610)-442-1017 |
| | Contact: J.D. Webb |
| | 1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 Tele<br>512-692-3699 Fax<br>e-mail: [e-mail] |

#### 2. DEVICE DESCRIPTION

The S.E.A.L. Fracture Fusion Tube provides a solution for fractures and for lengthening of small bones. The system allows controlled compression / distraction and early weight bearing. The articulating pin clamps allow adjustment around three axes and linear translation so that it can be used for comminuted intra-articular fractures or arthrodesis of the fixator design enables pins to be located in multi-planar arrangements, allowing the frame to be built around the fractures in the hand or foot.

#### Materials:

6061-T6 Aluminum 316L Stainless steel PTFE PEEK

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#### K140158

#### Function:

The S.E.A.L. Fracture Fusion Tube is indicated for stabilizing various fractures including open and/or comminuted fractures, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal and metatarsal bones

#### 3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

The S.E.A.L. Fracture Fusion Tube is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.

#### 4. INTENDED USE

The S.E.A.L. Fracture Fusion Tube is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.

#### 5. NON-CLINICAL TEST SUMMARY

Testing was performed following ASTM F1541-02 Annex 7.

The results of this analysis indicate that the S.E.A.L. Fracture Fusion Tube is equivalent to predicate devices.

#### 6. CLINICAL TEST SUMMARY

No clinical studies were performed

#### 7. CONCLUSIONS NONCLINICAL AND CLINICAL

D.N.E considers the S.E.A.L. Fracture Fusion Tube to be equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.

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Image /page/2/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the circle is a stylized image of an eagle. The eagle is facing to the right and has its wings spread.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

### May 29, 2014

DNE. LLC % J.D. Webb The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock. Texas 78681

Re: K140158

Trade/Device Name: S.E.A.L. Fracture Fusion Tube 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: April 17, 2014 Received: April 21, 2014

Dear Mr. Webb:

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 10 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. Iabeling, 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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I ederal 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. J.D. Webb

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education 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,

# Lori A. Wiggins

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K140158

Device Name

S.E.A.L. Fracture Fusion Tube

Indications for Use (Describe)

The S.E.A.L. Fracture Fusion Tube is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.

Type of Use (Select one or both, as applicable)

.. '

> Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Casey Li Hanley, Ph. D Division of Orthopedic Devices

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