(162 days)
No
The summary describes a mechanical implant and associated instrumentation, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is designed for use in the treatment of specific pathological conditions, indicating a therapeutic purpose.
No
This device is an implant designed to treat specific pathological conditions of the foot by blocking displacement and stabilizing the subtalar joint. It is a therapeutic device, not a diagnostic one that identifies or characterizes a disease.
No
The device description explicitly states it is a threaded implant made from titanium alloy, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant designed to treat a physical condition (hyperpronated foot and subtalar joint instability) by being physically inserted into the body.
- Device Description: The device is a threaded implant made of titanium alloy, designed for surgical insertion.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to examine specimens and provide diagnostic information. This device is a surgical implant used inside the body for treatment.
N/A
Intended Use / Indications for Use
The TalarLift STS arthroereisis implant is designed for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, allowing normal subtalar joint motion while blocking excessive promation and the resulting sequelae. The TalarLift STS is intended for the following pathological conditions resulting from disease, injury, or other trauma:
Hypermobile pes valgus:
Posterior tibial tendon dysfunction;
Severe pronation;
Subtalar instability;
Hypermobile flexible congenital flat foot.
Product codes
HWC
Device Description
The TalarLift STS consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, and corresponding instrumentation to facilitate insertion. The system consists of three configurations, conical, cylindrical, and anatomic. All three devices are manufactured from titanium alloy (Ti-6Al-4V) complying with ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, subtalar joint
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)
Non-clinical Test Summary: The following analyses were conducted: FEA was performed to determine worst case for mechanical testing Static compression test Insertion / expulsion test Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay. The testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device. The results of these evaluations indicate that the TalarLift STS is equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K093055, K032682, K142534, K041289, K080280
Reference Device(s)
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Fusion Orthopedics, LLC % J.D. Webb Regulatory Consultant The Orthomedix Group. Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
August 11, 2017
Re: K170624
Trade/Device Name: TalarLift STS Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 8, 2017 Received: August 9, 2017
Dear J.D. 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 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
1
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 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" (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.
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
510(k) Number (if known)
Device Name
TalarLift STS
See PRA Statement below.
Indications for Use (Describe)
The TalarLift STS arthroereisis implant is designed for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, allowing normal subtalar joint motion while blocking excessive promation and the resulting sequelae. The TalarLift STS is intended for the following pathological conditions resulting from disease, injury, or other trauma:
·Hypermobile pes valgus:
·Posterior tibial tendon dysfunction;
- ·Severe pronation;
·Subtalar instability;
·Hypermobile flexible congenital flat foot.
Type of Use (Select one or both, as applicable)
Y 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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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
510(k) Summary: TalarLift STS
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
| Date Prepared | May 9, 2017 |
|---|---|
| Submitted By | Fusion Orthopedics, LLC |
| 4135 S. Power Rd., Suite 110 | |
| Mesa, AZ 85212 | |
| 800-403-6876 | |
| Primary Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | TalarLift STS |
| Common Name | Subtalar spacer |
| Classification Name | Screw, fixation, bone |
| Class | II |
| Product Code | HWC |
| CFR Section | 21 CFR section 888.3040 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | CSTS Screw, OrthoPro (K093055) |
| Secondary Predicate | |
| Devices | STS Screw, OrthoPro (K032682) |
| HyProCure II, GraMedica (K142534) | |
| TALEX™ Subtalar Stabilization System, Vilex, Inc. (K041289) | |
| Sub-Talar Lok Implant, Instratek, Inc (K080280) | |
| Reference Predicate | |
| Devices | Kangli Pedicle Screw System (K140053 and K142290) |
| HammerTech® Fixation System, Fusion Orthopedics LLC (K161449) | |
| Device Description | The TalarLift STS consists of a threaded implant, designed to be inserted between the |
| posterior and middle facets of the subtalar joint, and corresponding instrumentation to | |
| facilitate insertion. The system consists of three configurations, conical, cylindrical, and | |
| anatomic. All three devices are manufactured from titanium alloy (Ti-6Al-4V) complying | |
| with ASTM F136. | |
| Indications for Use | The TalarLift STS arthroereisis implant is designed for use in the treatment of the |
| hyperpronated foot and stabilization of the subtalar joint. It is designed to block the | |
| posterior and inferior displacement of the talus, allowing normal subtalar joint motion while | |
| blocking excessive pronation and the resulting sequelae. The TalarLift STS is intended for | |
| the following pathological conditions resulting from disease, injury, or other trauma: | |
| • Hypermobile pes valgus; | |
| • Posterior tibial tendon dysfunction; | |
| • Severe pronation; | |
| • Subtalar instability; | |
| • Hypermobile flexible congenital flat foot. | |
| Materials | Titanium alloy (Ti-6Al-4V - ASTM F136) |
| Stainless steel (ASTM F899) | |
| Silicone | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The TalarLift STS is substantially equivalent to the predicate devices in terms of intended |
| use, design, materials used, mechanical safety and performances. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| FEA was performed to determine worst case for mechanical testing Static compression test Insertion / expulsion test Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay. The | |
| testing demonstrated that the subject device meets the recommended maximum | |
| endotoxin level of 20 EU per device. The results of these evaluations indicate that the TalarLift STS is equivalent to predicate | |
| devices. | |
| Clinical Test | |
| Summary | No clinical studies were performed |
| Conclusions: Non- | |
| clinical and Clinical | Fusion Orthopedics LLC considers the TalarLift STS to be equivalent to the predicate |
| devices listed above. This conclusion is based upon the devices' similarities in principles | |
| of operation, technology, materials and indications for use |
4