(54 days)
Not Found
No
The device description and intended use focus solely on a mechanical implant and its instrumentation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint, which are therapeutic purposes.
No
The device is described as an implantable screw for treating a hyperpronated foot and stabilizing the subtalar joint, which indicates a therapeutic or corrective function rather than a diagnostic one.
No
The device description clearly states it is a threaded implant made of Ti-6A1-4V 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:
- 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 Ortho-Pro STS Screw is a physical implant designed to be surgically inserted into the subtalar joint. It is a medical device used for treatment and stabilization, not for analyzing biological samples.
- Intended Use: The intended use describes the treatment of a physical condition (hyperpronated foot and subtalar joint stabilization) through surgical intervention.
Therefore, the Ortho-Pro STS Screw falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Ortho-Pro STS Screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. It is appropriate for the following conditions:
- Severely pronated foot
- Walking intemperance
- Calcaneal stance position greater than 5°
- Manually correctable deformities
- Mid-tarsal breech (arch pain)
- Forefoot varus greater than 10°
Product codes
HWC
Device Description
The Ortho-Pro STS Screw 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 implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. An internal hex-head allows for maximum torque with minimal risk of stripping. External rounded threads increase ease of insertion. This device is manufactured from Ti-6A1-4V alloy and is available in six sizes, 06.5mm to Ø11.5mm in 1mm increments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Not Found
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
OCT 2 2 2003
510(k) Summary
Date August 26, 2003
Submitter
Ortho-Pro LLC Box 515 4848 Highland Dr. Salt Lake City, UT 84117
Contact person
J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Common name
Bone screw
Classification name
Screw, fixation, bone (per 21 CFR section 888.3040 )
Equivalent Device
The STS Screw is similar in design, indications and material as the Kinetikos Subtalar MBA System (K960692).
Device Description
The Ortho-Pro STS Screw 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 implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. An internal hex-head allows for maximum torque with minimal risk of stripping. External rounded threads increase ease of insertion. This device is manufactured from Ti-6A1-4V alloy and is available in six sizes, 06.5mm to Ø11.5mm in 1mm increments.
Intended Use
The Ortho-Pro STS Screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela.
- · Severely pronated foot
- · Walking intemperance
- · Calcaneal stance position greater than 5°
- · Manually correctable deformities
- · Mid-tarsal breech (arch pain)
- · Forefoot varus greater than 10°
Summary of Technological Characteristics Compared to Predicate Device
- A minimally invasive, outpatient procedure ●
- Simplicity and accuracy
- . Completely reversible procedure with minimal dissection required
- Entirely extra-articular, therefore, no bone resection or drilling is required, reducing trauma to bone and ● surrounding tissue
- No bone cement required
- Cannulated and constructed of highly biocompatible titanium
- Radiopaque
- . Fully removable at skeletal maturity (in pediatric cases)
- . Strong wear characteristics (titanium alloy will not fragment or wear like silicone or polyethylene devices)
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three lines representing the body and head, and a flowing shape below representing arms or support. The figure is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.
Public Health Service
OCT 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ortho-Pro LLC C/o Mr. J. D. Webb 1001 Oakwood Boulevard Round Rock, TX 78681
Re: K032682
Trade/Device Name: Ortho-Pro STS Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: August 26, 2003 Received: September 4, 2003
Dear Mr. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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); 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.
2
Page 2 - Mr. J. D. Webb
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millman
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
3
510(k) number (if known): _ KO 3268 d
Device Name: Ortho-Pro STS Screw
Indications for Use:
Ortho-Pro STS Screw Indications for Use
The Ortho-Pro STS Screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. It is appropriate for the following conditions:
- Severely pronated foot
- · Walking intemperance
- · Calcaneal stance position greater than 5°
- Manually correctable deformities
- · Mid-tarsal breech (arch pain)
- · Forefoot varus greater than 10°
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
Prescription Use (per 21 CFR 801.109) OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional format 1-2-96)
)
Menh A. Melleman
(Division Sign-off) Division of General, Neurological and Restorative Devices
510(k) Number K032682