(90 days)
No
The summary describes a mechanical implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an implantable system used to treat a medical condition (hyperpronated foot and stabilization of the subtalar joint), which squarely falls under the definition of a therapeutic device.
No
This device is an implant designed to treat hyperpronated foot and stabilize the subtalar joint, which falls under therapeutic intervention, not diagnosis. Its purpose is to correct a condition, not to identify or monitor one.
No
The device description clearly states it is an "implant" intended to be "implanted into the sinus tarsi of the foot," describing a physical, hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "treatment of hyperpronated foot and stabilization of the subtalar joint." This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is an implant designed to be surgically placed in the foot. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, chemical reactions, or diagnostic measurements.
This device is a surgical implant, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The OsteoSpring FootJack™ Subtalar Implant System is in the treatment of hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but limited excessive pronation and resulting sequela. The OsteoSpring FootJack Implant System implants are intended for single patient use only.
Product codes
HWC
Device Description
The OsteoSpring FootJack™ subtalar implant is intended to be implanted into the sinus tarsi of the foot. It will be available in a range of sizes. The implant is a solid, one-piece, conical, thread shaped and cannulated design.
Materials:
Titanium Alloy ELI per ASTM F136.
Function:
The conical threaded design of the FootJack implant is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation and resulting sequela.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus tarsi of the 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)
The following tests were conducted:
- Finite Element Analysis .
- . Static compression testing
The results of this testing indicate that the OsteoSpring FootJack™ Implant met the acceptance criteria and withstood the load testing without functional failure or defect.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OsteoMed Subtalar Implant System - K031155, Instratek Subtalar Lok™ - K080280, BioArch™ Subtalar Implant - K070441
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
112658
510(k) Summary for the OsteoSpring FootJack™ Subtalar Implant System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the OsteoSpring FootJack™ Subtalar Implant System.
GENERAL INFORMATION 1.
Date Prepared: | September 7, 2011 |
---|---|
Trade Name: | OsteoSpring FootJack™ Subtalar Implant System |
Common Name: | Subtalar implant |
Classification Name: | Screw, fixation, bone |
Class: | II |
Product Code: | HWC |
CFR section: | 21 CFR section 888.3040 |
Device panel: | Orthopedic |
Legally Marketed | OsteoMed Subtalar Implant System - K031155 |
Predicate Devices: | Instratek Subtalar Lok™ - K080280 |
BioArch™ Subtalar Implant - K070441 | |
Submitter: | OsteoSpring Medical Inc. |
228 Hamilton Avenue, 3rd Floor | |
Palo Alto, CA 94301 | |
650-798-5284 Office | |
Contact: | J.D. Webb |
1001 Oakwood Blvd | |
Round Rock, TX 78681 | |
512-388-0199 | |
E-Mail: ortho.medix@sbcglobal.net |
2. DEVICE DESCRIPTION
The OsteoSpring FootJack™ subtalar implant is intended to be implanted into the sinus tarsi of the foot. It will be available in a range of sizes. The implant is a solid, one-piece, conical, thread shaped and cannulated design.
Materials:
Titanium Alloy ELI per ASTM F136.
Function:
.
The conical threaded design of the FootJack implant is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation and resulting sequela.
SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES 3.
The OsteoSpring FootJack™ subtalar implant is substantially equivalent to the OsteoMed Subtalar Implant System, Instratek Subtalar Lok™ and BioArch™ Subtalar Implant in terms of intended use, design, materials used, mechanical safety and performances.
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4. INTENDED USE
The OsteoSpring FootJack™ Subtalar Implant System is in the treatment of hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but limited excessive pronation and resulting sequela. The OsteoSpring FootJack Implant System implants are intended for single patient use only.
NON-CLINICAL TEST SUMMARY 5.
The following tests were conducted:
- Finite Element Analysis .
- . Static compression testing
The results of this testing indicate that the OsteoSpring FootJack™ Implant met the acceptance criteria and withstood the load testing without functional failure or defect.
6. CLINICAL TEST SUMMARY
No clinical studies were performed.
CONCLUSIONS NONCLINICAL AND CLINICAL 7.
The OsteoSpring FootJack™ Subtalar Implant System 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 and Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is drawn with thick, black lines, and the text is in a simple, sans-serif font. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OsteoSpring Medical, Inc. % The OrthoMedix Group, Inc. % Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock. Texas 78681
DEC 1 2 2011
Re: K112658
Trade/Device Name: OsteoSpring FootJack Subtalar Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: I-IWC Dated: September 7, 2011 Received: September 13, 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/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 vours.
For Pat the
Denise
Mark N. Melkerson 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): K | |2 6 5 8
OsteoSpring FootJack™ Subtalar Implant System_ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The OsteoSpring FootJack™ Subtalar Implant System is indicated for use in the treatment of hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but limited excessive pronation and resulting sequela. The OsteoSpring FootJack Implant System . implants are intended for single patient use only.
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)
Richard Owens to MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112658