(88 days)
No
The device description and intended use focus solely on the mechanical properties and surgical application of bone screws. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The TIGER TRACK® screw system is intended for permanent implantation to fix fractures and perform arthrodesis, which directly treats musculoskeletal conditions.
No
The TIGER TRACK® screw system is an orthopedic implant intended for fixation/arthrodesis procedures, not for diagnostic purposes. Its use involves surgical implantation for bone repair and reconstruction.
No
The device description clearly states it is a "screw system" made of materials like PEEK, Titanium, and Cobalt Chrome, intended for surgical implantation. This indicates a physical hardware device, not software.
Based on the provided text, the TIGER TRACK® screw system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "small bone extremity and large/long bone reconstruction fixation/arthrodesis procedures" and is "intended to be permanently implanted." This describes a surgical implant used directly on the patient's body for structural support and fixation.
- Device Description: The description details the physical characteristics of screws made from materials like PEEK, Titanium, and Cobalt Chrome. It discusses threads, shafts, and how they achieve compression or linkage of bone segments. This is consistent with a surgical implant.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The TIGER TRACK® screw system does not perform any such function. It is a physical device implanted within the body.
Therefore, the TIGER TRACK® screw system is a surgical implant, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
HWC
Device Description
The TIGER TRACK® screw system is intended for single use only, and is available in a range of different diameters, lengths and materials depending on the indication. The TIGER TRACK® screw system has two categories of screws: self-compressive screws and non-compressive screws.
The self-compressive screws have a distal and proximal thread, separated by a cylindrical shaft where the fracture or osteotomy line should be placed. The difference of pitch between the distal and proximal thread provides compression between both segments. The TIGER TRACK® snap-off Weil screw doesn't have a proximal thread, the compression is done by its head and the distal thread. The non-compressive screws have a full thread allowing surgeons to only link both segments without any compression.
All devices of the TIGER TRACK® screws system are monobloc components. The TIGER TRACK® screw system PEEK range is manufactured dry with grades of PEEK (Zeniva ZA-500) per ASTM F-2026 from Solvay Advanced Polymers released with predicate K133036, Titanium range is made of alloyed Titanium ISO 5832-3 / ASTM F-136 and released with predicate K131722, Snap-off threaded pin HV18XX range is made of Cobalt Chrome according to the ISO 5832-7 / ASTM F-1058 and released with predicate K120739.
The feature design of the TIGER TRACK® screw system is substantially equivalent to the design features of other devices previously cleared for market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bone extremities, foot, hand, distal or proximal metatarsal or metacarpal, first metatarsalphalangeal joint, interphalageal joint, distal radius, ulnar styloid, radial head, capirellumn, humeral head, glenoid, intercarpal distal and proximal, malleolar, patellar, osteochondral, talonavicular, tibeo-talar, cuboid, hind foot, humerus, femur, tibia.
Indicated Patient Age Range
Skeletally mature individuals
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Test Summary: The following tests were performed to demonstrate that the TIGER TRACK® Screw System is substantially equivalent to 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 System met the acceptance criteria.
Clinical Test Summary: No clinical tests were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043142, K030900, K131722, K041189, K071540, K041456, K070617, K895389, K063298, K132912, K130859, K120739, K133036, K133235, K022599
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
0
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the | |
| time to review instructions, search existing data sources, gather and maintain the data needed and complete | |
| and review the collection of information. Send comments regarding this burden estimate or any other aspect | |
| of this information collection, including suggestions for reducing this burden, to: | |
| Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov | Department of Health and Human Services |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of | |
| information unless it displays a currently valid OMB number " |
3
Traditional 510(k) Summary
as required by section 807.92(c).
Synchro-Medical TIGER TRACK® Device K151241
| Submitter: | Synchro Medical
6 rue des Merisiers
F-68920 Wettolsheim les Erlen
FRANCE |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Danilo Campani
President
Phone: +33(0)3 89 23 75 64
Fax:+33(0)3 89 27 14 52
Email: dcampani@synchro-medical.com |
| Date Prepared | 07/07/2015 |
| Device Class | Class II |
| Trade Name | TIGER TRACK®. |
| Common Name | Synchro-Medical TIGER TRACK® Screw System |
| Classification Name
and Number | Smooth or threaded metallic bone fixation fastener
21 CFR 888.3040 |
| Classification Panel: | Orthopedic |
| Product Code | HWC |
| Predicate Devices | (K043142 & K030900) Inion Ltd., OTPSTM Biodegradable Screws;
(K131722), I.T.S GmbH, Extremity Fixation Systems; (K041189), Arthrex,
TRIMit Family; (K071540) Small Bone Innovations International, SBI
Titanium Threaded Pin, Percufix; (K041456) & (K070617), Fournitures
Hospitalières Industries, Snap-off Screws & Cannulated Screws; (K895389),
Biomet, (Ex-Depuy), S.O.C Pin; (K063298), OsteoMed L. P., Headless
Cannulated Screw System; (K132912) In2Bones, DUAFIT Interphalangeal
Implant; (K130859), Arthrosurface, Hammertoe Correction System,
(K120739) Tornier, Aequalis Adjustable Modular Reverse Shoulder System;
(K133036) Amendia, Apollo Suture Anchor System, (K133235) Threaded
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
only, and is available in a range of different diameters, lengths
and materials depending on the indication. The TIGER
TRACK® screw system has two categories of screws: self-
compressive screws and non-compressive screws.
The self-compressive screws have a distal and proximal thread,
separated by a cylindrical shaft where the fracture or osteotomy
line should be placed. The difference of pitch between the distal
and proximal thread provides compression between both
segments. The TIGER TRACK® snap-off Weil screw doesn't
have a proximal thread, the compression is done by its head and
the distal thread. The non-compressive screws have a full thread
allowing surgeons to only link both segments without any
compression.
All devices of the TIGER TRACK® screws system are
monobloc components. The TIGER TRACK® screw system
PEEK range is manufactured dry with grades of PEEK (Zeniva
ZA-500) per ASTM F-2026 from Solvay Advanced Polymers
released with predicate K133036, Titanium range is made of
alloyed Titanium ISO 5832-3 / ASTM F-136 and released with
predicate K131722, Snap-off threaded pin HV18XX range is
made of Cobalt Chrome according to the ISO 5832-7 / ASTM
F-1058 and released with predicate K120739.
The feature design of the TIGER TRACK® screw system is
substantially equivalent to the design features of other devices
previously cleared for market. |
| Intended Use /
Indications | The TIGER TRACK® screw system is intended for small bone
extremity 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, diameters 3.5mm or
smaller (1.8mm, 2.2mm, 2.5mm, 2.9mm, 3.0mm), is indicated
for use in fixation 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 interphalangeal joint; fixation of
osteotomies for Hallux Valgus treatment (such as Scarf,
Chevron, etc.); Akin type osteotomy; distal radius fractures
(articular fragments). ulnar styloid fractures, radial head
fractures, capirellumn fractures, humeral head fractures, glenoid
fractures, intercarpal distal and proximal fusions, malleolar
fractures, patellar fractures, osteochondral fractures,
talonavicular fusions, 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 spinal use.
The devices described in this manual must be accompanied with
a form of immobilisation suited to the pathology being treated |
| Materials: | All devices of the TIGER TRACK® screws system are
monobloc components. The TIGER TRACK® screw system
PEEK range is manufactured dry with grades of PEEK (Zeniva
ZA-500) per ASTM F-2026 from Solvay Advanced Polymers
released with predicate K133036, Titanium range is made of
alloyed Titanium ISO 5832-3 / ASTM F-136 and released with
predicate K131722, Snap-off threaded pin HV18XX range is
made of Cobalt Chrome according to the ISO 5832-7 / ASTM
F-1058 and released with predicate K120739. |
4
5
6
| 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
Summary | The following tests were performed to demonstrate that the
TIGER TRACK® Screw System is substantially equivalent to
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
System met the acceptance criteria. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test Summary | No clinical tests were performed. |
7
| 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. |