(53 days)
Not Found
No
The 510(k) summary describes a mechanical implant and associated instrumentation. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are non-clinical and focus on mechanical properties.
Yes
The device is intended to treat pathological conditions such as hypermobile pes valgus, posterior tibial tendon dysfunction, and severe pronation, which indicates a therapeutic purpose.
No
The NuGait Subtalar Implant System is described as an "arthroereisis implant designed to stabilize the subtalar joint," indicating it is a therapeutic device inserted into the body to correct a pathological condition, not a device used to identify or analyze a medical condition.
No
The device description clearly states the device is a physical implant made of titanium alloy, 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 restrict subtalar pronation and stabilize the subtalar joint. This is a therapeutic intervention performed on a patient's body.
- Device Description: The device is a physical implant made of titanium alloy, intended for surgical insertion.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are used in vitro (outside the body) to diagnose diseases or conditions.
This device is clearly a surgical implant, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The NuGait™ Subtalar Implant System restricts excessive subtalar pronation in the downward, forward, and medial planes, providing for a more normal subtalar joint motion in patients. The NuGait Subtalar Implant System 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.
The NuGait Subtalar Implant System implants are intended for single use only.
Product codes
HWC
Device Description
The NuGait Subtalar Implant System consists of a one-piece arthroereisis implant designed to stabilize the subtalar joint of the hyperpronated foot and associated instrumentation. The NuGait implant is constructed of Ti-6Al-4V ELI titanium alloy and is offered in 5 sizes to fit a range of anatomies. The subject device is also cannulated to allow precise insertion when used with a guide wire and system instrumentation. The outer surface of the implant features a helical thread to aid fixation within the sinus tarsi. Each NuGait is packaged individually and sterilized via gamma radiation. These devices are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subtalar joint, 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)
Non-Clinical Performance Data: In order to support substantial equivalence, the following non-clinical performance data was gathered: . Bending Strength Evaluation Clinical Performance Data: Clinical performance data were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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/0 description: The image shows the logo for Ascension Orthopedics. The logo features a black triangle on the left side, with the text "Ascension Orthopedics" to the right of the triangle. The text is in a simple, sans-serif font.
ascension orthopedics, inc .8700 Cameron Road, Suite 100 AUSTIN, TEXAS 78754
Summary of Safety and Effectiveness
Summary of Safety and Effectiveness
| Sponsor: | Ascension Orthopedics, Inc.
8700 Cameron Road, Suite 100
Austin, TX 78754-3832
AUG 19 2011 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bradley W. Strasser
Regulatory Affairs Specialist
512-836-5001 ext. 1541 |
| Date: | 24 June 2011 |
| Trade Name: | NuGait ™ Subtalar Implant System |
| Common Name: | Subtalar Arthroereisis Implant |
| Product Code: | HWC - Screw, Fixation, Bone |
| Classification: | 21 CFR §888.3040 - Smooth or threaded metallic bone fixation fastener. |
| Panel: | Orthopedic |
| Predicate Device: | Sub-Talar Lok ™ Arthroereisis Implant System; K080280, cleared 14 March 2008; manufactured by Instratek, Inc. |
| Device Description: | The NuGait Subtalar Implant System consists of a one-piece arthroereisis implant designed to stabilize the subtalar joint of the hyperpronated foot and associated instrumentation. The NuGait implant is constructed of Ti-6Al-4V ELI titanium alloy and is offered in 5 sizes to fit a range of anatomies. The subject device is also cannulated to allow precise insertion when used with a guide wire and system instrumentation. The outer surface of the implant features a helical thread to aid fixation within the sinus tarsi. Each NuGait is packaged individually and sterilized via gamma radiation. These devices are intended for single use only. |
1
Intended Use: The NuGait Subtalar Implant System restricts excessive subtalar pronation in the downward, forward, and medial planes, providing for a more normal subtalar joint motion in patients. The NuGait Subtalar Implant System 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. Basis of Substantial Equivalence: The NuGait Subtalar Implant System has the same technological characteristics and intended use as the predicate device. The subject device is also manufactured from equivalent materials. These points and engineering analysis form the basis for substantial equivalence, and the differences between the subject device and predicate do not raise new issues of safety or effectiveness. Non-Clinical Performance Data: In order to support substantial equivalence, the following non-clinical performance data was gathered: . Bending Strength Evaluation Clinical Performance Data: Clinical performance data were not needed for this
device.
Confidential Pane 15 of 87
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ascension Orthopedies, Inc. % Mr. Bradley W. Strasser 8700 Cameron Road, Suite 100 Austin, TX 78754-3832
AUG 1 9 2011
Re: K111799
Trade/Device Name: NuGaif™ Subtalar Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 24th, 2011 Received: June 27th, 2011
Dear Mr. Strasser,
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.
3
Page 2 - Mr. Bradley W. Strasser
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eric P. Kettl
مرحم Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 111799
Device Name:
NuGait™ Subtalar Implant System
Indications for Use:
The NuGait™ Subtalar Implant System restricts excessive subtalar pronation in the downward, forward, and medial planes, providing for a more normal subtalar joint motion in patients. The NuGait Subtalar Implant System 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.
The NuGait Subtalar Implant System implants are intended for single use only.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Evaluation (ODE)
for M. Melkerm
(Division Sigh Off) Division of Surgical, Orthopedic, and Restorative Devices
10(k) Number K111799
Confidential Pane 13 of 87