(124 days)
Not Found
No
The device description focuses on the physical characteristics, materials, and intended surgical use of a bone fixation system. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies mentioned are engineering analyses and benchtop testing, not studies of algorithmic performance.
Yes
The device is used for internal bone fixation for bone fractures, fusions, or osteotomies, which is a therapeutic purpose.
No
The device is described as an implantable system for internal bone fixation in the ankle and foot, specifically for fractures, fusions, or osteotomies. Its function is to provide structural support and aid in fusion, not to diagnose medical conditions.
No
The device description clearly states that the device is an implant made of PEEK and titanium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot." This describes a surgical implant used within the body to treat a physical condition.
- Device Description: The description details a physical implant (wedge, pins, screws) made of materials like PEEK and titanium, designed to be surgically placed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to physically stabilize bone.
N/A
Intended Use / Indications for Use
The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:
· Opening wedge osteotomies of Hallux Valgus
· Evans lengthening osteotomies
· Metatarsal/cuneiform arthrodesis
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot. The implant is available in a range of sizes and footprints to suit the individual anatomical conditions of the patient. Additionally, the wedge is fabricated and manufactured with two different materials: 1) Polyetheretherketone (PEEK) with tantalum markers and titanium pins (Ti 6Al-4V ELI). 2) Titanium (Ti 6Al-4V ELI).
The implant is hollow to permit packing with autogenous bone graft to help fusion. A C-Shape footprint of the device is also offered for use in procedures where bone graft is not required. The implant has two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) through the wedge to provide internal fixation. Devices are offered with either midline or offset screw pockets.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the TARSA-LINK Stand-Alone Wedge Fixation System components with components from any other system or manufacturer. The TARSA-LINK Stand-Alone Wedge Fixation System components should never be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle and Foot
Indicated Patient Age Range
Not Found
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)
Finite Element Analysis, engineering rationale and benchtop testing was presented to demonstrate the substantial equivalency of the TARSA-LINK Stand-Alone Wedge Fixation System
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Tarsa-Link Wedge Fixation System (K150368), MaxLock Extreme® System (K113048), MaxLock Extreme® System (K120157), Mini MaxLock Extreme® Plating System (K120157), BIOFOAM® Wedge (K142724), Pro-Link® Wedge System (K141905)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(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 features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure, emphasizing the department's role and national scope. The logo is simple, yet conveys a sense of care and public service.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2016
Life Spine Incorporated Mr. Randy Lewis General Manager 13951 South Quality Drive Huntley, Illinois 60142
Re: K161037
Trade/Device Name: Tarsa-Link Stand-Alone Wedge Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: July 15, 2016 Received: July 18, 2016
Dear Mr. Lewis:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 (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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
ions for Use
510(k) Number (if known) K161037
Device Name
TARSA-LINK Stand-Alone Wedge Fixation System
Indications for Use (Describe)
The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:
· Opening wedge osteotomies of Hallux Valgus
· Evans lengthening osteotomies
· Metatarsal/cuneiform arthrodesis
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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3
510(k) Summary
The TARSA-LINK Stand-Alone Wedge Fixation System
| Submitted By: | Life Spine
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis
General Manager
Life Spine
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | August 12th, 2016 |
| Trade Name: | TARSA-LINK Stand-Alone Wedge Fixation System |
| Classification: | HRS, CFR 888.3030, Class II
HWC, CFR 888.3040, Class II |
| Predicate Device: | Tarsa-Link Wedge Fixation System (K150368) |
| Additional Predicate: | MaxLock Extreme® System (K113048)
MaxLock Extreme® System (K120157)
Mini MaxLock Extreme® Plating System (K120157)
BIOFOAM® Wedge (K142724)
Pro-Link® Wedge System (K141905) |
Device Description:
The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot. The implant is available in a range of sizes and footprints to suit the individual anatomical conditions of the patient. Additionally, the wedge is fabricated and manufactured with two different materials: 1) Polyetheretherketone (PEEK) with tantalum markers and titanium pins (Ti 6Al-4V ELI). 2) Titanium (Ti 6Al-4V ELI).
The implant is hollow to permit packing with autogenous bone graft to help fusion. A C-Shape footprint of the device is also offered for use in procedures where bone graft is not required. The implant has two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) through the wedge to provide internal fixation. Devices are offered with either midline or offset screw pockets.
4
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the TARSA-LINK Stand-Alone Wedge Fixation System components with components from any other system or manufacturer. The TARSA-LINK Stand-Alone Wedge Fixation System components should never be reused under any circumstances.
Intended Use of the Device:
The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:
- Opening wedge osteotomies of Hallux Valgus ●
- Evans lengthening osteotomies ●
- Metatarsal/cuneiform arthrodesis
Technological Characteristics:
The TARSA-LINK Stand-Alone Wedge Fixation System is substantially equivalent to the predicate systems in terms of design, materials, and indications for use.
Material:
The TARSA-LINK Stand-Alone Wedge Fixation System is manufactured from either implantable grade Polyetheretherketone (PEEK) per ASTM F2026 or Titanium (Ti 6Al-4V ELI) per ASTM F136. The device incorporates tantalum markers per ASTM F560, and implantable grade titanium (Ti 6Al-4V ELI) per ASTM F136.
Performance Data:
Finite Element Analysis, engineering rationale and benchtop testing was presented to demonstrate the substantial equivalency of the TARSA-LINK Stand-Alone Wedge Fixation System
Conclusion:
The TARSA-LINK Stand-Alone Wedge Fixation System was shown to be substantially equivalent to the previously cleared devices in indications for use, design, function, and materials used.