(62 days)
Not Found
No
The summary describes a physical implant and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is intended to treat a medical condition (hyperpronated foot and stabilize the subtalar joint) and block forward and medial displacement of the talus, which are therapeutic actions.
No
Explanation: The device is an implant designed to treat a medical condition (hyperpronated foot and subtalar joint instability) by surgical implantation, not to diagnose a condition.
No
The device description explicitly states it is a "one-piece device made of Titanium Alloy intended to be implanted," indicating it is a physical implant, 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Solana Surgical Gaitway Implant System is a physical implant made of titanium alloy that is surgically placed in the foot. It directly interacts with the body's structure.
- Intended Use: The intended use is to treat a physical condition (hyperpronated foot) by stabilizing a joint through surgical implantation.
The description clearly indicates a surgically implanted device used for structural support and correction within the body, which is the opposite of an in vitro diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Solana Surgical LLC, Gaitway Implant System is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward and medial displacement of the talus, thus blocking excessive pronation and the resulting sequela.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Solana Surgical Gaitway Implant is a one-piece device made of Titanium Alloy intended to be implanted in the Sinus Tarsi of the foot. The implant is available in a range of sizes (5) ranging from 6.5 mm to 11.5 mm. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the production of this implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Sinus Tarsi of the foot, 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)
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.
K093820 Memometal SubFix Arthroereisis Implant, K080280 Instratek, INC.Sub-Talar Lok, Model 7-11 mm, K071456 Arthrex Pro Stop Plus
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
K122738 (pg. i of 2.)
Section 5. - 510(k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
Prepared: Applicant: August 31, 2012 Solana Surgical, LLC 6363 Poplar Ave, Suite 434 Memphis, TN 38119 Phone: (901) 818-1860 Fax: (855) 540-1861 Contact: Rebecca Wahl
Common Name: Device Trade Name: Device Classification Name:
Device Classification: Reviewing Panel: Regulation Number: Product Code: Predicate Devices:
Subtalar Arthroereisis Implant Gaitway Implant System Smooth or threaded metallic bone fixation fastener. Class II Orthopedic 21 CFR 888.3040 HWC K093820 Memometal SubFix Arthroereisis Implant K080280 Instratek, INC.Sub-Talar Lok, Model 7-11 mm K071456 Arthrex Pro Stop Plus
Device Description:
The Solana Surgical Gaitway Implant is a one-piece device made of Titanium Alloy intended to be implanted in the Sinus Tarsi of the foot. The implant is available in a range of sizes (5) ranging from 6.5 mm to 11.5 mm. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the production of this implant.
Indications for use:
The Solana Surgical LLC, Gaitway Implant System is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward and medial displacement of the talus, thus blocking excessive pronation and the resulting sequela.
Summary Comparison to Predicate Devices:
The Solana Surgical device is similar to the Memometal Subfix™ Subtalar Arthroereisis Implant (K093820), the Instratek, Inc. Sub-Talar Lok, Model 7-11 mm (K080280) and the Arthrex Pro Stop Plus (K071456). Each device is placed into the sinus tarsi of the foot, allowing normal subtalar joint motion while blocking excessive pronation. The Memometal and Instratek devices are made of titanium alloy and the Arthrex device is made of Poly L - Lactide (PLLA). The Solana Surgical, Memometal, Instratek and Arthrex devices are conical in shape so as to fit into the anatomy of the sinus tarsi. Each system is cannulated to accept a guide wire for ease of Solana Surgical - October 18, 2012
1
)4122738
implantation. All devices are: intended for single use only; intended for surgical implantation longer than 30 days; are placed into the subtalar sinus tarsi.
Indications for use, geometry and material composition were considered in evaluating safety and effectiveness relative to predicate devices. The subject device is constructed of material that is identical to the Memometal and Instratek devices and greatly exceeds the mechanical strength characteristics of the Arthrex device. Given the similar geometry and equivalent or greater strength, the Solana Surgical device should not introduce new concerns of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 7, 2012
Solana Surgical, LLC % Rebecca Wahl Vice President Research and Development 6363 Poplar Ave. Suite 434 Memphis, Tennessee 38119
Re: K122738
Trade/Device Name: Gaitway Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC · Dated: August 31, 2012 Received: September 6, 2012
Dear Ms. Wahl:
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 for ass stated in the energean of 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 or any 1 ederal statute and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Ms. Wahl
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device thated adverse overse (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 rr you acce//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 mote the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation emailing 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 Tou may obtain 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ | 122738 Device Name: Gaitway Implant System Indications for Use:
The Solana Surgical LLC, Gaitway Implant System is intended to treat the hyperpronated The Solana Surgical EDC, Guttway implants of earling of the marked to block forward and 1001 and Submize the Subanar John. 11-19-19-19-19 to and the resulting sequela.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
1122738 510(k) Number _
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