Synchro-Medical TIGER TRACK Screw System

K151241 · Synchro Medical · HWC · Aug 7, 2015 · Orthopedic

Device Facts

• Record ID: K151241
• Device Name: Synchro-Medical TIGER TRACK Screw System
• Applicant: Synchro Medical
• Product Code: HWC · Orthopedic
• Decision Date: Aug 7, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TIGER TRACK® screw system is intended for small bone extremities and large/long bone reconstruction fixation/ arthrodesis procedures for general use in skeletally mature individuals. The TIGER TRACK @ screw system is intended to be permanently implanted without any other additional device and are delivered sterile. The TIGER TRACK® screw system, for diameters 3.5mm or smaller(1.8mm, 2.2mm, 2.9mm), 3.0mm), is indicated for use in fixation for small bone fractures or for small bone reconstruction including: mono or bicortical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; Weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalageal joint; fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fragments). ulnar styloid fractures, radial head fractures, capirellumn fractures, humeral head fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, tibeo-talar fusions, and cuboid fusions. The TIGER TRACK® screw system, for diameters 4.5mm and 7.0mm, is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degenerative transformations of long bones in the hind foot and large bone intra-articular fractures of the humerus, femur, and tibia. The size of the chosen screw should be adapted to the specific indication. The TIGER TRACK ® screw system is not for spiral use. The devices described in this manual must be accompanied with a form of immobilisation suited to the pathology being treated.

Device Story

TIGER TRACK® screw system consists of monobloc metallic/PEEK screws for bone fixation/arthrodesis. Available in self-compressive (distal/proximal threads with shaft) and non-compressive (full thread) configurations. Snap-off Weil screw variant uses head and distal thread for compression. Implanted by surgeons in clinical settings to stabilize fractures or osteotomies. Requires external immobilization post-procedure. Benefits include mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical tests were performed.

Technological Characteristics

Monobloc screws. Materials: PEEK (Zeniva ZA-500, ASTM F-2026), Titanium alloy (ISO 5832-3 / ASTM F-136), Cobalt Chrome (ISO 5832-7 / ASTM F-1058). Configurations: self-compressive and non-compressive. Delivered sterile.

Indications for Use

Indicated for skeletally mature individuals requiring fixation or arthrodesis of small bone extremities (foot/hand) and large/long bone reconstruction. Specific indications include fractures, osteotomies (e.g., Weil, Scarf, Chevron, Akin), fusions (MTP, interphalangeal, intercarpal, talonavicular, tibeo-talar, cuboid), pseudoarthrosis, and degenerative transformations. 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

• Inion Ltd., OTPSTM Biodegradable Screws (K043142 & K030900)
• I.T.S GmbH, Extremity Fixation Systems (K131722)
• Arthrex, TRIMit Family (K041189)
• Small Bone Innovations International, SBI Titanium Threaded Pin, Percufix (K071540)
• Fournitures Hospitalières Industries, Snap-off Screws & Cannulated Screws (K041456 & K070617)
• Biomet, S.O.C Pin (K895389)
• OsteoMed L. P., Headless Cannulated Screw System (K063298)
• In2Bones, DUAFIT Interphalangeal Implant (K132912)
• Arthrosurface, Hammertoe Correction System (K130859)
• Tornier, Aequalis Adjustable Modular Reverse Shoulder System (K120739)
• Amendia, Apollo Suture Anchor System (K133036)
• Threaded Peek K-Wire MTP Solutions (K133235)
• Newdeal K Wire (K022599)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

August 7, 2015

Synchro Medical % Mark F. Schenk Mark F. Schenk Consulting 505 Berks Place West Lawn, Pennsylvania 19609

Re: K151241

Trade/Device Name: Synchro-Medical TIGER TRACK® Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 8, 2015 Received: June 9, 2015

Dear Mr. Schenk:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Lori A. Wiggins -S

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: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K151241

Device Name

Synchro-Medical TIGER TRACK® Screw System

#### Indications for Use (Describe)

The TIGER TRACK® screw system is intended for small bone extremities and large/long bone reconstruction fixation/ arthrodesis procedures for general use in skeletally mature individuals. The TIGER TRACK @ screw system is intended to be permanently implanted without any other additional device and are delivered sterile.

The TIGER TRACK® screw system, for diameters 3.5mm or smaller(1.8mm, 2.2mm, 2.9mm), 3.0mm), is indicated for use in fixation for small bone fractures or for small bone reconstruction including: mono or bicortical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; Weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalageal joint; fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fragments). ulnar styloid fractures, radial head fractures, capirellumn fractures, humeral head fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, tibeo-talar fusions, and cuboid fusions.

The TIGER TRACK® screw system, for diameters 4.5mm and 7.0mm, is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degenerative transformations of long bones in the hind foot and large bone intra-articular fractures of the humerus, femur, and tibia. The size of the chosen screw should be adapted to the specific indication.

The TIGER TRACK ® screw system is not for spiral use. The devices described in this manual must be accompanied with a form of immobilisation suited to the pathology being treated.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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## Traditional 510(k) Summary

as required by section 807.92(c).

# Synchro-Medical TIGER TRACK® Device K151241

| Submitter: | Synchro Medical<br>6 rue des Merisiers<br>F-68920 Wettolsheim les Erlen<br>FRANCE |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Danilo Campani<br>President<br>Phone: [phone]<br>Fax:[phone]<br>Email: [e-mail] |
| Date Prepared | 07/07/2015 |
| Device Class | Class II |
| Trade Name | TIGER TRACK®. |
| Common Name | Synchro-Medical TIGER TRACK® Screw System |
| Classification Name<br>and Number | Smooth or threaded metallic bone fixation fastener<br>21 CFR 888.3040 |
| Classification Panel: | Orthopedic |
| Product Code | HWC |
| Predicate Devices | (K043142 & K030900) Inion Ltd., OTPSTM Biodegradable Screws;<br>(K131722), I.T.S GmbH, Extremity Fixation Systems; (K041189), Arthrex,<br>TRIMit Family; (K071540) Small Bone Innovations International, SBI<br>Titanium Threaded Pin, Percufix; (K041456) & (K070617), Fournitures<br>Hospitalières Industries, Snap-off Screws & Cannulated Screws; (K895389),<br>Biomet, (Ex-Depuy), S.O.C Pin; (K063298), OsteoMed L. P., Headless<br>Cannulated Screw System; (K132912) In2Bones, DUAFIT Interphalangeal<br>Implant; (K130859), Arthrosurface, Hammertoe Correction System,<br>(K120739) Tornier, Aequalis Adjustable Modular Reverse Shoulder System;<br>(K133036) Amendia, Apollo Suture Anchor System, (K133235) Threaded<br>Peek K-Wire MTP Solutions, and (K022599) Newdeal K Wire. |
| Previous Submissions | There are no previous submissions |
| Device Description | The TIGER TRACK® screw system is intended for single use<br>only, and is available in a range of different diameters, lengths<br>and materials depending on the indication. The TIGER<br>TRACK® screw system has two categories of screws: self-<br>compressive screws and non-compressive screws.<br><br>The self-compressive screws have a distal and proximal thread,<br>separated by a cylindrical shaft where the fracture or osteotomy<br>line should be placed. The difference of pitch between the distal<br>and proximal thread provides compression between both<br>segments. The TIGER TRACK® snap-off Weil screw doesn't<br>have a proximal thread, the compression is done by its head and<br>the distal thread. The non-compressive screws have a full thread<br>allowing surgeons to only link both segments without any<br>compression.<br><br>All devices of the TIGER TRACK® screws system are<br>monobloc components. The TIGER TRACK® screw system<br>PEEK range is manufactured dry with grades of PEEK (Zeniva<br>ZA-500) per ASTM F-2026 from Solvay Advanced Polymers<br>released with predicate K133036, Titanium range is made of<br>alloyed Titanium ISO 5832-3 / ASTM F-136 and released with<br>predicate K131722, Snap-off threaded pin HV18XX range is<br>made of Cobalt Chrome according to the ISO 5832-7 / ASTM<br>F-1058 and released with predicate K120739.<br><br>The feature design of the TIGER TRACK® screw system is<br>substantially equivalent to the design features of other devices<br>previously cleared for market. |
| Intended Use /<br>Indications | The TIGER TRACK® screw system is intended for small bone<br>extremity and large/long bone reconstruction<br>fixation/arthrodesis procedures for general use in skeletally<br>mature individuals. The TIGER TRACK® screw system is<br>intended to be permanently implanted without any other<br>additional device and are delivered sterile.<br>The TIGER TRACK® screw system, diameters 3.5mm or<br>smaller (1.8mm, 2.2mm, 2.5mm, 2.9mm, 3.0mm), is indicated<br>for use in fixation small bone fractures or for small bone<br>reconstruction including: mono or bicortical osteotomies in the<br>foot or hand; distal or proximal metatarsal or metacarpal<br>osteotomies; Weil osteotomy; fusion of the first<br>metatarsalphalangeal joint and interphalangeal joint; fixation of<br>osteotomies for Hallux Valgus treatment (such as Scarf,<br>Chevron, etc.); Akin type osteotomy; distal radius fractures<br>(articular fragments). ulnar styloid fractures, radial head<br>fractures, capirellumn fractures, humeral head fractures, glenoid<br>fractures, intercarpal distal and proximal fusions, malleolar<br>fractures, patellar fractures, osteochondral fractures,<br>talonavicular fusions, tibeo-talar fusions, and cuboid fusions.<br>The TIGER TRACK® screw system, for diameters 4.5mm and<br>7.0mm, is indicated for use for fractures, corrective<br>osteotomies, pseudoarthrosis, degenerative transformations of<br>long bones in the hind foot and large bone intra-articular<br>fractures of the humerus, femur, and tibia.<br>The size of the chosen screw should be adapted to the specific<br>indication.<br>The TIGER TRACK® screw system is not for spinal use.<br>The devices described in this manual must be accompanied with<br>a form of immobilisation suited to the pathology being treated |
| Materials: | All devices of the TIGER TRACK® screws system are<br>monobloc components. The TIGER TRACK® screw system<br>PEEK range is manufactured dry with grades of PEEK (Zeniva<br>ZA-500) per ASTM F-2026 from Solvay Advanced Polymers<br>released with predicate K133036, Titanium range is made of<br>alloyed Titanium ISO 5832-3 / ASTM F-136 and released with<br>predicate K131722, Snap-off threaded pin HV18XX range is<br>made of Cobalt Chrome according to the ISO 5832-7 / ASTM<br>F-1058 and released with predicate K120739. |

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| Statement of | The purpose of this submission is to obtain market clearance for |
|---------------|------------------------------------------------------------------|
| Technological | the proposed the TIGER TRACK® Screw System. The TIGER |
| Comparison | TRACK® Screw System and its predicate devices have similar |
| | indications for use and similar functionality. All devices are |
| | manufactured using materials with a long history of use in |
| | orthopaedic implants. |

| Nonclinical Test<br>Summary | The following tests were performed to demonstrate that the<br>TIGER TRACK® Screw System is substantially equivalent to<br>other predicate devices. Pullout force per ASTM F564-10 Torsional Strength per ASTM F-543 The results of these studies showed the TIGER TRACK® Screw<br>System met the acceptance criteria. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test Summary | No clinical tests were performed. |

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| Conclusion | The TIGER TRACK® Screw System is substantially equivalent |
|------------|------------------------------------------------------------------|
| | to its predicate devices. This conclusion is based upon the fact |
| | the TIGER TRACK® Screw System and its predicate devices |
| | have the same indications for use and have a similar design. |