(418 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical placement of a screw implant, with no mention of AI or ML technologies.
Yes
The device is indicated for use in the treatment of a medical condition (hyperpronated foot and stabilization of the subtalar joint) and is designed to block excessive pronation and its resulting sequela.
No
Explanation: The device is an implantable screw designed to treat a physical condition (hyperpronated foot and subtalar joint stabilization), not to diagnose a condition. Its function is therapeutic, not diagnostic.
No
The device description clearly states it is a threaded implant and corresponding instrumentation, which are physical hardware components.
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 stabilization) by being inserted into the body. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a threaded implant and surgical instrumentation. This aligns with a surgical device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Ortho-Pro CSTS 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 .
- Calcaneal stance position greater than 5° .
- Manually correctable deformities .
- . Mid-tarsal breech (arch pain)
- Forefoot varus greater than 10° .
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Ortho-Pro CSTS 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 conical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. External flattened threads increase ease of insertion. It is available in five sizes, Ø8mm to Ø12mm 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)
Non-clinical Test Summary:
The following tests were conducted:
- . Compressive testing
Clinical Test Summary:
No clinical studies were performed
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.
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
§ 888.3040 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
K093055 '/2
510(k) Summary for the CSTS Screw
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the CSTS Screw
NOV 2 2 2010
Date Prepared: November 5, 2010
| 1. Submitter: | Contact Person: | |
|---|---|---|
| Ortho-Pro LLC | J.D. Webb | |
| 3450 Highland Drive, Ste 303 | The OrthoMedix Group, Inc. | |
| Salt Lake City, UT 84106 | 1001 Oakwood Blvd | |
| Telephone: 801-746-1056 | Round Rock, TX 78681 | |
| Telephone/Fax: 512-388-0199 |
-
- Trade name: Common Name: Classification Name:
CSTS Screw Subtalar spacer Screw, fixation, bone 21 CFR section 888.3040 HWC Class II
- Trade name: Common Name: Classification Name:
-
Predicate or legally marketed devices which are substantially equivalent: 3. OrthoPro STS Screw (K032682) Futura Biomedical Arthrorisis Implant (K032902)
র্ব Description of the device:
The Ortho-Pro CSTS 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 conical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. External flattened threads increase ease of insertion. It is available in five sizes, Ø8mm to Ø12mm in 1mm increments.
Materials:
Ti-6Al-4V alloy per ASTM F136 Commercially pure titanium per ASTM F67
Function:
The CSTS Screw blocks the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation.
Substantial equivalence claimed to predicate devices 5.
CSTS Screw is substantially equivalent to the OrthoPro STS Screw (K032682) and Futura Biomedical Arthrorisis Implant (K032902) in terms of intended use, design, materials used, mechanical safety and performances. The table below compares the features and characteristics of the CSTS Screw to these predicate devices.
| Device
Name
Items | CSTS Screw | STS Screw | Futura Biomedical
Arthrorisis Implant |
|-------------------------|------------|-----------|------------------------------------------|
| Sponsor | OrthoPro | OrthoPro | Futura Biomedical |
| 510(k) Number | -- | K032682 | K032902 |
| Indications for Use | [1] | [2] | [3] |
1
| Device
Name | CSTS Screw | STS Screw | Futura Biomedical
Arthrorisis Implant |
|-------------------------|----------------------------------|----------------------------------|------------------------------------------|
| Items | | | |
| Material | Ti-6Al-4V alloy per
ASTM F136 | Ti-6Al-4V alloy per
ASTM F136 | Ti-6Al-4V alloy per
ASTM F136 |
| CP Ti Plasma spray | Yes | No | No |
| Profile | Conical | Cylindrical | Conical |
| Thread | Yes | Yes | Yes |
| Non-threaded
section | Yes | Yes | No |
| Cross holes | Yes | No, longitudinal
grooves | Yes |
| Cannulated | Yes | Yes | Yes |
| Dimensions | Ø8-12mm | Ø6.5-11.5mm | Ø7-12mm |
| Sterile | No | No | ? |
ల్. Intended Use:
The CSTS 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 allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. It is appropriate for the following conditions:
- Severely pronated foot .
- Calcaneal stance position greater than 5° .
- . Manually correctable deformities
- . Mid-tarsal breech (arch pain)
- Forefoot varus greater than 10° .
7. Non-clinical Test Summary:
The following tests were conducted:
- . Compressive testing
-
- Clinical Test Summary:
No clinical studies were performed
Conclusions Nonclinical and Clinical: g.
The CSTS Screw is similar to the predicate devices in terms of indications for use, design, material, and function. .
KO9305
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ortho-Pro. LLC % The OrthoMedix Group, Inc. % Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, TX 78681
NOV 2 2 2010
Re: K093055 Trade/Device Name: CSTS Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 5, 2010 Received: November 9, 2010
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. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. J.D. Webb
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/ReportalProblem/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,
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
NOV 2 2 2010
510(k) Number (if known): K093055
Device Name:
NOV 2 6 LUIN
Indications for Use:
Ortho-Pro CSTS Screw Indications for Use
The Ortho-Pro CSTS 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 .
- Calcaneal stance position greater than 5° .
- Manually correctable deformities .
- . Mid-tarsal breech (arch pain)
- Forefoot varus greater than 10° .
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sonette for mxn
(Division Sign of)
(Division Sign-Ø Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093055