(103 days)
Not Found
No
The description focuses on a mechanical implant and its instrumentation, with no mention of AI/ML terms or functionalities.
Yes
The device is described as treating the hyperpronated foot and stabilizing the subtalar joint, which indicates a therapeutic purpose.
No
The device is described as an implant used for treatment and stabilization, not for diagnosis. It mechanically blocks displacement rather than providing diagnostic information.
No
The device description clearly states it is a "threaded implant" and "corresponding instrumentation," which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description: The Trilliant Surgical Subtalar Implant is a physical implant designed to be surgically inserted into the body to treat a specific anatomical issue (hyperpronated foot and subtalar joint instability).
- Intended Use: The intended use describes a surgical intervention and stabilization of a joint, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Trilliant Surgical Subtalar Implant is indicated for 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 (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Trilliant Surgical 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 implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. It is available in six sizes, Ø7mm 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:
- Compression testing comparing predicate and Trilliant Surgical Subtalar Implant. ●
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
510(k) Summary for the Trilliiant Surgical Subtalar Implant
K103183
p 1/3
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Trilliant Surgical Subtalar Implant
Date Prepared: October 22, 2010
-
- Submitter:
Trilliant Surgical LTD 602 Sawyer Street, Suite 120 Houston, TX 77007 Telephone: 214-288-1035
- Submitter:
Contact Person: J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199
| 2. Trade name: | Trilliant Surgical Subtalar Implant |
|---|---|
| Common Name: | Subtalar spacer |
| Classification Name: | Screw, fixation, bone |
| 21 CFR section 888.3040 | |
| HWC | |
| Class II |
3. Predicate or legally marketed devices which are substantially equivalent:
The Trilliant Surgical Subtalar Implant is substantially equivalent to the following devices:
- Subtalar MBA System, K960692 (Kinetikos Medical, Inc.) �
- HyProCure Subtalar Implant System, K042030 (GraMedical Technologies, LLC) �
- . Subtalar Arthroereisis Implant, K093820 (Memometal Technologies)
4. Description of the device:
The Trilliant Surgical 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 implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. It is available in six sizes, Ø7mm to Ø12mm in 1mm increments.
Materials:
Ti-6Al-4V alloy per ASTM F136
Function:
The Trilliant Surgical Subtalar Implant blocks the posterior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation.
5. Substantial equivalence claimed to predicate devices
The Trilliant Surgical Subtalar Implant is substantially equivalent to the Subtalar MBA System, HyProCure Subtalar Implant System and Subtalar Arthroereisis Implant devices in terms of intended use, design, and materials used. The table below compares the features and characteristics of the Trilliant Surgical Subtalar Implant to these predicate devices.
| Device
Name
Items | Trilliiant Surgical
Subtalar Implant | Subtalar MBA
System | HyProCure
Subtalar Implant
System | Subtalar
Arthroereisis
Implant |
|-------------------------|-----------------------------------------|----------------------------|-------------------------------------------|--------------------------------------|
| Sponsor | Trilliant, LTD | Kinetikos Medical,
Inc. | GraMedica
Medical
Technologies, LLC | Memometal
Technologie |
| 510(k) Number | N/A | K960692 | K042030 | K093820 |
- 8 2011
1
| Device
Name
Items | Trilliiant Surgical
Subtalar Implant | Subtalar MBA
System | HyProCure
Subtalar Implant
System | K103138
Subtalar
Arthroereisis
Implant |
|------------------------------------------|-----------------------------------------|-----------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Device
Classification
Name | Screw, fixation,
bone | Screw, fixation,
bone | Screw, fixation,
bone | Screw, fixation,
bone |
| Product Code | HWC | HWC | HWC | HWC |
| Regulation # | 21 CFR 888.3040 | 21 CFR 888.3040 | 21 CFR 888.3040 | 21 CFR 888.3040 |
| Classification | II | II | II | II |
| Indications for
Use | [1] see at end of
table | [2] see at end of
table | [3] see at end of
table | [4] see at end of
table |
| Implant material | Titanium alloy per
ASTM F136 | Titanium alloy per
ASTM F136 | Titanium alloy per
ASTM F136 | Titanium alloy per
ASTM F136 |
| Diameter
Length | Ø - 7mm-12mm
L - 12.75mm-
19.50mm | Ø - 6mm-12mm
L - 15mm | | Ø - 6.5mm-
11.5mm |
| Profile /anatomy
location | Threaded cylinder
/ sinus tarsi | Threaded cylinder
/sinus tarsi | Threaded cylinder
/sinus tarsi
Smooth cone /
sinus canalis | Threaded cylinder
/sinus tarsi
Shallow thread to
smooth cone /
sinus canalis |
| Cannulated | Yes | Yes | Yes | Yes |
| Rounded nose
for ease of
insertion | Yes | Yes | Yes | No |
| Packaged sterile | No, sterilized at
hospital | No, sterilized at
hospital | Yes | Yes |
[1] The Trilliant Surgical subtalar implant is indicated for 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.
[2] The KMI Subtalar MBA System™ is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is design to block the anterior displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela:
- Severely pronated foot. .
- . Walking intemperance.
- . Calcaneal stance position greater than 5°
- . Manually correctable deformity
- . Mid-tarsal breech (arch pain)
- . Forefoot varus greater than 10°
[3] The HyProCure Subtalar Implant is indicated for use in the treatment of the hyperpronated foot by stabilization of the subtalar joint. The implant is designed to block anterior, and/or plantarflexion of the talus, while allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
[3] The Memometal Technologies' Subfix Arthroereisis Implant is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing subtalar joint motion but blocking excessive pronation and the resulting sequela.
2
6. Intended Use:
K103138,p3/3
The Trilliant Surgical subtalar implant is indicated for 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.
7. Non-clinical Test Summary:
The following tests were conducted:
- Compression testing comparing predicate and Trilliant Surgical Subtalar Implant. ●
8. Clinical Test Summary
No clinical studies were performed
റ്റ. Conclusions Nonclinical and Clinical
The Trilliant Surgical Subtalar Implant is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle with three stylized wing segments, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
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 Blvd. Round Rock, Texas 78681
FEB - 8 2", i
Re: K103183
Trade/Device Name: Trilliant Surgical Subtalar Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: January 28, 2011 Received: February 3, 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
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
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/ReportaProblem/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.
Aley B. D.K
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K |0 3 | 8 3
Device Name: Trilliant Surgical Subtalar Implant
Indications for Use:
· The Trilliant Surgical Subtalar Implant is indicated for the use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, downward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.
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)
for M. Melkerson
(Division Sign-Off) rthopedic, Division di Surgical, Divisionative Devices
510(k) Number K/03/83