(50 days)
Not Found
None
No
The summary describes a physical implant for stabilizing a joint and contains no mention of software, algorithms, or AI/ML terms.
Yes
The device is indicated for use in the "treatment of the hyperpronated foot by stabilization of the subtalar joint," which is a therapeutic purpose.
No
The device, HyProCure Subtalar Implant, is described as being used for treatment by stabilizing the subtalar joint and blocking excessive pronation. This indicates a therapeutic function, not a diagnostic one.
No
The device is described as an "implant" and is intended for "stabilization of the subtalar joint," which clearly indicates a physical, hardware-based medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is an "implant" designed to be placed within the subtalar joint to stabilize the foot. This is a physical device used in vivo (within the body), not a test performed on a sample in vitro (outside the body).
- Intended Use: The intended use is to treat a physical condition (hyperpronated foot) by stabilizing a joint. This is a therapeutic intervention, not a diagnostic test.
Therefore, the HyProCure Subtalar Implant is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
The HyProCure Subtalar Implant is indicated for use in the treatment of the hyperpronated foot by stabilization of the subtalar joint. The implant is designed to block anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
This device is prescription use only.
Product codes
HWC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a circular seal or logo. The text around the perimeter reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized graphic consisting of three parallel, curved lines that resemble a stylized human figure or symbol. The lines are thicker at the top and taper towards the bottom, creating a sense of movement or flow.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2004
Michael E. Graham, DPM Chief Executive Officer Graham Medical Technologies, LLC 45700 Schoenherr Road Shelby Township, Michigan 48315
Re: K042030
Trade/Device Name: HyProCure 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: July 23, 2004 Received: July 28, 2004
Dear Dr. Graham:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revious your beenmined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 2017 - 11:51
devices that have been reclassified in accordance with the provisions of the Federal Food, DINA de neces that have been require approval of a premarket approval application (PMA). and Cosmetter For (110) that as nevice, subject to the general controls provisions of the Act. The 1 ou may, there, mans of the Act include requirements for annual registration, listing of general bonuroly provision practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassinou toontrols. Existing major regulations affecting your device can Inay be subject to sach additions, 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 I lease be devised that I Drivision that your device complies with other requirements of the Act that I Dri has intates and regulations administered by other Federal agencies. You must of any I catales and the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Far 6077, lacemig (21 (OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality byovens (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 -- Michael E. Graham, DPM
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally prematics notification: "The stars in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrise is. Jour 301) 594-4659. Also, please note the regulation entitled, Connact the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionmance and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
W Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use:
510(k) Number: K042030 HYPROCURE SUBTALAR IMPLANT SYSTEM Device Name:
The HyProCure Subtalar Implant is indicated for use in the treatment of the hyperpronated foot by stabilization of the subtalar joint. The implant is designed to block anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
This device is prescription use only.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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