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° .

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.

AI/ML Overview

The provided document describes the 510(k) summary for the CSTS Screw, a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical trials to establish new safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" and "reported device performance" are typically framed in terms of demonstrating substantial equivalence to a predicate device through non-clinical testing and comparing design features. There isn't a direct "acceptance criteria" in the sense of a numerical diagnostic performance target as would be seen in an AI/diagnostic device study. Instead, the "acceptance criteria" are implied by demonstrating that the new device is as safe and effective as the predicate.

Feature/Test	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (CSTS Screw)
Functional Equivalence	Must achieve the same clinical function as predicate devices: blocking posterior/inferior displacement of the talus, allowing normal subtalar motion, blocking excessive pronation.	Function: "blocks the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation."
Material Equivalence	Must use substantially equivalent or same materials as predicate devices for biocompatibility and mechanical properties.	Material: Ti-6Al-4V alloy per ASTM F136; Commercially pure titanium per ASTM F67. (Same as predicates)
Design Equivalence (Key Features)	Must have comparable design characteristics to predicates (e.g., cannulated, threaded, profile).	Profile: Conical (similar to Futura, different from STS). Thread: Yes (similar to both). Cannulated: Yes (similar to both). Cross holes: Yes (different from STS, similar to Futura).
Indications for Use Equivalence	Must have the same or a very similar intended use.	Indications for Use: "treatment of the hyperpronated foot and stabilization of the subtalar joint..." and specific conditions. (Identical to predicates as per comparison table)
Compressive Strength	Must demonstrate comparable mechanical strength to predicate devices. (No specific numerical acceptance value provided in the summary, implied by comparison with predicate)	Compressive testing was conducted. (Specific results not detailed in summary, but presumably met internal standards for equivalence).
Sterility	Must meet sterility requirements if intended to be sterile.	Sterile: No (consistent with predicate STS Screw).

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily a non-clinical bench testing study combined with a comparison to predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Sample Size: Not explicitly stated as a "sample size" in the conventional sense of a clinical trial. The "test set" here refers to the samples of the CSTS Screw that underwent compressive testing. The exact number of screws tested is not provided in the summary.
Data Provenance: The testing appears to be prospective bench testing conducted specifically for this submission. There is no mention of country of origin for data as it's a bench test, not clinical data from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. For a device like the CSTS Screw, "ground truth" and expert adjudication are typically associated with clinical outcomes, image interpretation, or pathological diagnosis. This submission relies on substantial equivalence and non-clinical engineering tests. There's no mention of experts establishing a "ground truth" for the non-clinical tests described.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, typically in diagnostic studies. This document describes non-clinical mechanical testing, where results are objective measurements rather than subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a subtalar screw, a physical implant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing: The "ground truth" would be the objective measurements obtained from the compressive testing (e.g., force at failure), and the engineering specifications/standards (e.g., ASTM F136 for materials). The "truth" of substantial equivalence is established by comparing these test results and design features to those of the predicate devices, which have already been deemed safe and effective.

8. The Sample Size for the Training Set

Not applicable. Training sets are relevant for machine learning algorithms. This is a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. Training sets and their ground truth are not relevant for this type of device submission.

Summary

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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

1. Trade name: Common Name: Classification Name:
  CSTS Screw Subtalar spacer Screw, fixation, bone 21 CFR section 888.3040 HWC Class II
Predicate or legally marketed devices which are substantially equivalent: 3. OrthoPro STS Screw (K032682) Futura Biomedical Arthrorisis Implant (K032902)

র্ব Description of the device:

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.

DeviceNameItems	CSTS Screw	STS Screw	Futura BiomedicalArthrorisis Implant
Sponsor	OrthoPro	OrthoPro	Futura Biomedical
510(k) Number	--	K032682	K032902
Indications for Use	[1]	[2]	[3]

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DeviceName	CSTS Screw	STS Screw	Futura BiomedicalArthrorisis Implant
Items
Material	Ti-6Al-4V alloy perASTM F136	Ti-6Al-4V alloy perASTM F136	Ti-6Al-4V alloy perASTM F136
CP Ti Plasma spray	Yes	No	No
Profile	Conical	Cylindrical	Conical
Thread	Yes	Yes	Yes
Non-threadedsection	Yes	Yes	No
Cross holes	Yes	No, longitudinalgrooves	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
1. 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

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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

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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

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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

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

Regulation Number and Section

§ 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.