(33 days)
Not Found
No
The 510(k) summary describes a mechanical implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to treat a medical condition (hyperpronated foot and excessive pronation) and stabilize a joint, which falls under the definition of a therapeutic device designed to alleviate or treat a disease or condition.
No
The device is described as an implant intended to treat hyperpronated foot by stabilizing the subtalar joint and blocking excessive pronation. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states it is a physical implant made of Ti 6Al-4V ELI, intended to be surgically implanted. This is a hardware device, not software.
Based on the provided information, 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.
- Device Description: The IFS Subtalar Implant is a physical implant made of Ti 6Al-4V ELI that is surgically placed into the sinus tarsi of the foot.
- Intended Use: Its intended use is to treat hyperpronated foot and stabilize the subtalar joint by physically blocking excessive motion.
The device does not perform any tests on biological samples. It is a physical implant used for structural support and stabilization within the body.
N/A
Intended Use / Indications for Use
The IFS Subtalar Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Product codes
HWC
Device Description
The IFS Subtalar Implant is a one-piece device made of Ti 6Al-4V ELI intended to be implanted into the sinus tarsi of the foot. The implant is designed in 6 diameter and length sizes (7mm through 12mm and 13mm through 18mm, respectively). The implant which is used in the treatment of excessive motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, sinus tarsi, 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)
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
Image /page/0/Picture/0 description: The image shows the logo for Internal Fixation Systems (IFS). The logo consists of a circular graphic on the left and the letters "IFS" on the right. Below the logo, the words "Internal Fixation Systems" are written out in a smaller font. The graphic appears to be a stylized representation of bones or some other medical device.
KII3399
12
DEC 2 0 2011
Internal Fixation Systems, Inc. 510(k) Summary
| Company Name: | Internal Fixation Systems, Inc. 10100 N.W. 116th Way, Suite 18 Miami, Florida 33178 |
|---|---|
| Contact Name: | Christopher Endara 10100 N.W. 116th Way, Suite 18 Miami, Florida 33178 (305) 884-5993 |
| Trade Name: | IFS Subtalar Implant |
| Common Name: | Bone Fixation Fasteners |
| Regulation Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| Regulation Number: | 21 CFR 888.3040 |
| Regulatory Class: | II |
| Device Product Code: | HWC |
| Substantially Equivalent Devices: | Nexa Subtalar Arthrorisis Implant (K032902) Osteomed Subtalar Implant System (K031155) |
| Device Description: | The IFS Subtalar Implant is a one-piece device made of Ti 6Al-4V ELI intended to be implanted into the sinus tarsi of the foot. The implant is designed in 6 diameter and length sizes (7mm through 12mm and 13mm through 18mm, respectively). The implant which is used in the treatment of excessive motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation. |
ﻳ
1
Image /page/1/Picture/0 description: The image shows the logo for Internal Fixation Systems (IFS). The logo consists of a circle with a design inside, followed by the letters "IFS" in a bold, sans-serif font. Below the logo, the words "Internal Fixation Systems" are written in a smaller font.
- The IFS Subtalar Implant is intended to treat hyperpronated Intended Use: foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
- Technological The IFS Subtalar Implant is substantially equivalent to the Characteristics predicate devices with respect to the design, function, and Comparison: material. The implants have the same overall diameters, lengths, and material composition.
- Sterilization IFS Subtalar Implant will be distributed non-sterile. The devices are sterilized by the end user per the AAMI Guidelines Information: "Good Hospital Practice: Steam Sterilization and Sterility Assurance" and ANSI/AAMI/ISO 11737 guidelines to achieve the Sterility Assurance Level (SAL) of 10-6.
- Conclusion: There are no significant differences between the subtalar implant and the other implants as listed in the Substantially Equivalent Devices. The IFS Subtalar Implant and the predicate devices have similar design attributes, material, and intended use thus is substantially equivalent.
ally
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Internal Fixation Systems, Inc. % Mr. Christopher Endara 10100 N.W. 116th Way, Suite 18 Miami, Florida 33178
DEC 2 0 2011
Re: K113399 Trade/Device Name: IFS Subtalar Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 7, 2011 Received: November 17, 2011
Dear Mr. Endara:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Mr. Christopher Endara
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,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): 长川33 ዓ
Device Name: IFS Subtalar Implant
Indications for Use: The IFS Subtalar Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark Melfeeson
(Division Sig. Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
10113399 510(k) Number