The Disco Subtalar Implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.

Device Description

The Disco Subtalar Implant 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 leading end of the implant is cylindrical in shape and is approximately half of the overall length of the device, with the remaining length being spherical. The full length of the implant incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. Internal threads are machined in the spherical end of the implant and are for use with a removal tool.

AI/ML Overview

The Disco Subtalar Implant's 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria in the manner typically understood for AI/ML-based medical devices (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth). This is a traditional medical device, not an AI/ML diagnostic tool.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and design characteristics, rather than clinical efficacy studies.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit from Document)	Reported Device Performance
Material Composition	Ti-6Al-4V alloy per ASTM F136	Disco Subtalar Implant uses Ti-6Al-4V alloy per ASTM F136.
Functional Equivalence	Block posterior and inferior displacement of the talus, allow normal subtalar joint motion while blocking excessive pronation.	"The Disco Subtalar Implant blocks the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation."
Mechanical Safety/Performance	Equivalent static compression and pull-out strength compared to predicate devices.	"The results of this testing indicate that the Disco Subtalar system is equivalent to predicate devices. Static compression and pull-out testing was performed."
Design Equivalance	Threaded implant, cylindrical leading end (approx. half length), spherical remaining length, center cannula, internal threads for removal tool.	Device description matches these features. Geometric change from predicate noted, but implied to be within acceptable variation for equivalence.
Intended Use	Treatment of hyperpronated foot, stabilization of subtalar joint, blocking forward and medial displacement of talus, allowing normal subtalar joint motion but limiting excessive pronation.	Matching statement in "Indications for Use" section.

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

Sample Size: Not applicable. The "tests" mentioned are non-clinical (static compression and pull-out testing on the device itself), not studies on a test set of patient data.
Data Provenance: Not applicable. The data comes from mechanical testing of the device.

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

Not applicable. Ground truth, in the context of diagnostic AI/ML devices, relates to patient outcomes or expert interpretations. For this mechanical device, "ground truth" relates to engineering specifications and material properties, which are verified through standard engineering tests.

4. Adjudication Method for the Test Set

Not applicable. There was no 'test set' of patient data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. The document explicitly states: "No clinical studies were performed." This is a mechanical implant device, not a diagnostic tool typically evaluated with MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used

For mechanical properties: Engineering standards and specifications (e.g., ASTM F136 for material, established benchmarks for static compression and pull-out strength based on predicate devices).
For intended use/function: Clinical consensus on the biomechanics of subtalar joint stabilization and correction of hyperpronation, as embodied by the predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set.

Summary of Device Acceptance:

The acceptance of the Disco Subtalar Implant by the FDA (as indicated by the 510(k) clearance K111834) was based on its successful demonstration of substantial equivalence to already legally marketed predicate devices (Trilliant Twist Subtalar Implant - K103183 and ProStop - K071456).

The study that "proves the device meets the acceptance criteria" in this context is the non-clinical testing summary where:

Static compression and pull-out testing was performed.
The results indicated that the Disco Subtalar system is equivalent to predicate devices in these mechanical properties.
The device's materials (Ti-6Al-4V alloy per ASTM F136), function, intended use, and design (despite a geometry change from the predicate) were also considered substantially equivalent.

The FDA's decision letter confirms this equivalence, allowing the device to be marketed. No clinical studies were required or performed for this 510(k) submission, as per standard regulatory pathways for certain types of mechanical implants claiming substantial equivalence.

Summary

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510(k) Summary for the Disco Subtalar Implant

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Disco Subtalar Implant

1. GENERAL INFORMATION

Date Prepared: June 17, 2011
Trade Name: Disco Subtalar Implant
Common Name: Subtalar spacer
Classification Name: Screw, fixation, bone
Class: II
Product Code: HWC
CFR section: 21 CFR section 888.3040
Device panel: Orthopedic
Legally Marketed Trilliant Twist Subtalar Implant - Trilliant Surgical, LTD, K103183
Predicate Device: ProStop - Arthrex, K071456
Submitter: Trilliant Surgical LTD602 Sawyer Street, Suite 120Houston, TX 77007Telephone: 214-288-1035
Contact: J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199e-mail: ortho.medix@sbcglobal.net

2. DEVICE DESCRIPTION

Change from Predicate:

The change from the predicate device is a geometry change.

Materials:

Ti-6Al-4V alloy per ASTM F136

Function:

The Disco Subtalar Implant blocks the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation.

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3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

The Disco Subtalar Implant is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.

4. INTENDED USE

5. NON-CLINICAL TEST SUMMARY

Static compression performed.

The results of this testing indicate that the Disco Subtalar system is equivalent to predicate devices. Static compression and pull-out testing was performed

6. CLINICAL TEST SUMMARY

No clinical studies were performed

7. CONCLUSIONS NONCLINICAL AND CLINICAL

The Disco Subtalar Implant is substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Trilliant Surgical LTD % The OrthoMedix Group, Inc. % Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

DEC - 6 2011

Re: K111834

Trade/Device Name: Disco Subtalar Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Il Product Code: HWC Dated: October 25, 2011 Received: November 1, 2011

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

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Page 2 - Mr. J.D. Webb

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/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.

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Disco Subtalar Implant

Indications for Use:

Prescription Use X (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)

Michael Owens for mxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111834

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.