(39 days)
Not Found
No
The 510(k) summary describes a mechanical implant and surgical tools, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is described as an "arthroereisis implant" that "restricts excessive subtalar pronation" and provides for "more normal subtalar joint motion in patients" for various pathological conditions, indicating a therapeutic intent to treat or alleviate a medical condition.
No
The device is an implant designed to restrict excessive subtalar pronation, which is a treatment rather than a diagnostic function. Its description focuses on stabilization and physical characteristics for implantation, not on identifying a condition.
No
The device description clearly states it is an "implant" and describes physical components like threads, cannulation, dilators, and drivers, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Instratek Sub-Talar Lok is an implant designed to be surgically placed within the human body (specifically, the subtalar joint). It is a physical device that restricts movement.
- Intended Use: The intended use describes the device's purpose in treating specific pathological conditions by physically stabilizing a joint. It does not involve analyzing biological specimens.
Therefore, based on the provided information, the Instratek Sub-Talar Lok is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Instratek Sub-Talar Lok arthroereisis implant restricts excessive subtalar pronation in all three planes, providing for a more normal subtalar joint motion in patients. The Sub-Talar Lok is intended for the following pathological conditions resulting from disease, injury, or other trauma.
• Hypermobile pes valgus
• Posterior tibial tendon dysfunction
• Severe pronation
• Subtalar instability
• Hypermobile flexible congenital flat foot
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Instratek Sub-Talar Lok Implant is designed to stabilize the subtalar joint of the hyperpronated foot. The implant is conical shaped with external threads of uniform depth and pitch. The device is cannulated for use with a guide wire. The product will be provided with a procedure kit containing: Five (5) dilators sized 7 through 11 mmTen Sub-Talar Lok implants, two each of five sizesRegular driver, 4.3mm hex headRescue driver, threaded
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subtalar joint of the hyperpronated foot
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)
Not Found
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
SECTION 5. 510(K) SUMMARY
| Submission
Correspondent: | Instratek, Inc.
210 Spring Hill Drive
Suite 130
Spring, TX 77386
USA
Phone: 281-890-8020
Fax: 281-890-8068
Email: jeff@instratek.com
Contact: Mr. Jeff Seavey
Vice President
MAR 14 2008 |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date summary prepared: | February 1, 2008 |
| Device trade name: | Sub-Talar Lok Implant |
| Device common name: | Subtalar Implant |
| Device classification name: | Screw, Fixation, Bone.
HWC at 21 CFR Part 880.3040 |
| Legally marketed device to
which the device is
substantially equivalent: | K032902, Futura Conical Subtalar Implant, Nexa Orthopedics
K031155, Extremity Talar-Fit Implant, Osteomed. |
| Description of the device: | The Instratek Sub-Talar Lok Implant is designed to stabilize the
subtalar joint of the hyperpronated foot. The implant is conical
shaped with external threads of uniform depth and pitch. The device
is cannulated for use with a guide wire. The product will be provided
with a procedure kit containing:
Five (5) dilators sized 7 through 11 mmTen Sub-Talar Lok implants, two each of five sizesRegular driver, 4.3mm hex headRescue driver, threaded |
1
| Intended use of the device: | The Instratek Sub-Talar Lok arthroereisis implant restricts excessive
subtalar pronation in all three planes, providing for a more normal
subtalar joint motion in patients. The Sub-Talar Lok is intended for
the following pathological conditions resulting from disease, injury, or
other trauma. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • Hypermobile pes valgus |
| | • Posterior tibial tendon dysfunction |
| | • Severe pronation |
| | • Subtalar instability |
| | • Hypermobile flexible congenital flat foot |
| Technological
characteristics: | The proposed device has the same technological characteristics as
the predicate devices. |
| Conclusions: | The results of the comparison of design, materials, intended use and
technological characteristics demonstrate that the device is as safe
and effective as the legally marketed predicate devices. |
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2008
Instratek, Inc. % Mr. Jeff Seavey 210 Spring Hill Drive Suite 130 The Woodlands, TX 77386
Re: K080280 Trade/Device Name: Sub-Talar Lok Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 1, 2008 Received: February 7, 2008
Dear Mr. Seavey:
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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Mr. Jeff Seavey
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark W. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4. INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K080280 |
|---|---|
| Device Name: | Sub-Talar Lok Implant |
| Indications for Use: | The Instratek Sub-Talar Lok arthroereisis implant |
| restricts excessive subtalar pronation in all three | |
| planes, providing for a more normal subtalar joint | |
| motion in patients. The Sub-Talar Lok is intended for | |
| the following pathological conditions resulting from |
-
Hypermobile pes valgus .
disease, injury, or other trauma. -
. Posterior tibial tendon dysfunction
-
. Severe pronation
-
t Subtalar instability
-
Hypermobile flexible congenital flat foot 9
× 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)
Nil RP Oshman from
(Division Sign Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K080280