(160 days)
No
The description focuses on the mechanical design and function of a physical implant and its instrumentation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the treatment of a medical condition (hyperpronated foot and stabilization of the subtalar joint).
No
The provided text describes a medical implant (Disco Subtalar Implant) designed for treatment and stabilization of the subtalar joint. Its function is to block displacement, allowing normal motion while limiting excessive pronation. This is a therapeutic device, not one that identifies or diagnoses a condition.
No
The device description clearly states it is a threaded implant and corresponding instrumentation, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The Disco Subtalar Implant is a physical implant designed to be surgically inserted into the subtalar joint of the foot. It is a mechanical device used to treat a physical condition (hyperpronated foot and subtalar joint instability).
- Intended Use: The intended use is to physically block displacement of the talus and stabilize the subtalar joint, not to analyze biological samples.
The information provided clearly describes a surgical implant, not a device used for testing biological samples in a lab setting.
N/A
Intended Use / Indications for Use
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.
Product codes
HWC
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.
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
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
Key Metrics
Not Found
Predicate Device(s)
Trilliant Twist Subtalar Implant - Trilliant Surgical, LTD, K103183, ProStop - Arthrex, K071456
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
DEC - 6 2011
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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 LTD |
| 602 Sawyer Street, Suite 120 |
| Houston, TX 77007 |
| Telephone: 214-288-1035 |
| Contact: J.D. Webb |
| 1001 Oakwood Blvd |
| Round Rock, TX 78681 |
| 512-388-0199 |
| e-mail: ortho.medix@sbcglobal.net |
2. 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.
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
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.
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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
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:
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.
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