(61 days)
Not Found
No
The device description and intended use clearly define a physical implant for surgical intervention, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is described as "treating the hyperpronated foot by stabilizing the subtalar joint" and is implanted to "restore the arch of the foot," which are therapeutic actions.
No
The provided text describes a subtalar implant used for treatment (stabilizing the subtalar joint and blocking displacement), not for diagnosing conditions.
No
The device description clearly states it is a physical implant made of titanium alloy or PEEK-OPTIMA®, intended for surgical implantation. 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Subtalar Implant is a physical device made of titanium alloy or PEEK-OPTIMA® that is surgically implanted into the sinus tarsi of the foot. Its purpose is to mechanically stabilize the subtalar joint and treat hyperpronation.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples from the patient. The device's function is purely mechanical and structural.
Therefore, the Subtalar Implant falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Subtalar Implant is indicated for use in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, and medial displacement of the talus, thereby limiting the excessive eversion of the hindfoot. Examples include, but are not limited to:
- Symptomatic acquired flat foot treatment in children and adolescents .
- Symptomatic congenital flexible flat foot .
- Tarsal coalitions when associated with the flatfoot deformity .
- Posterior tibial tendon dysfunction with supple feet .
- Paralytic flat foot .
- Subtalar Instability .
- Severely pronated foot .
Product codes
HWC
Device Description
The Subtalar Implant is a one-piece device comprised of titanium alloy or PEEK-OPTIMA® intended to be implanted into the sinus tarsi of the implant is available in eight sizes to accommodate a wide range of patient sizes. The device is used to stabilize the subtalar joint by restoring the arch of the foot and block anterior movement of the talus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus tarsi
Indicated Patient Age Range
children and adolescents
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 Testing: Mechanical testing confirmed that the Subtalar Implant meets the mechanical needs of the subtalar joint and will function within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
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
$p.^{i}/_{1}$
JUL 3 1 2007
Image /page/0/Picture/3 description: The image shows the logo for Biomet Orthopedics, Inc. The word "BIOMET" is in a bold, sans-serif font, with the letters connected. Below the word "BIOMET" is the text "ORTHOPEDICS, INC." in a smaller, sans-serif font. The logo is simple and professional, and it is likely used on the company's products and marketing materials.
510(k) Summary Subtalar Implant
May 30, 2007 Preparation Date: Applicant / Sponsor: Biomet Sports Medicine Elizabeth Wray Contact Person: Proprietary Name: Subtalar Implant Bone fixation device Common Name: Classification Name: Class II
- HWC- Smooth or threaded metallic bone fixation fastener (888.3040) .
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Subtalar MBA® Implant System- K960692, 07/23/1996, Kinetikos Medical Incorporated (KMI) Subtalar Arthrorisis Implant (Conical Subtalar Implant or CST) K032902, 12/15/2003, Nexa Orthopedics- Previously Futura Biomedical Kalix Implant- K001231, 07/11/2000, New Deal- An Integra LifeSciences Company
Device Description:
The Subtalar Implant is a one-piece device comprised of titanium alloy or PEEK-OPTIMA® intended to be implanted into the sinus tarsi of the implant is available in eight sizes to accommodate a wide range of patient sizes. The device is used to stabilize the subtalar joint by restoring the arch of the foot and block anterior movement of the talus.
Indications for Use/Intended Use:
The Subtalar Implant is indicated for use in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, and medial displacement of the talus, thereby limiting the excessive eversion of the hindfoot.
Examples include, but are not limited to:
- Symptomatic acquired flat foot treatment in children and adolescents .
- . Symptomatic congenital flexible flat foot
- Tarsal coalitions when associated with the flatfoot deformity .
- . Posterior tibial tendon dysfunction with supple feet
- Paralytic flat foot .
- Subtalar Instability .
- Severely pronated foot .
Summary of Technologies:
The technological characteristics (materials, design, sizing, and indications) of the Subtalar Implant are similar or identical to the predicate device or other previously cleared devices.
Non-Clinical Testing: Mechanical testing confirmed that the Subtalar Implant meets the mechanical needs of the subtalar joint and will function within its intended use.
5-1
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc, except Subtalar MBA®, PEEK-OPTIMA®, and Kalix(B).
Mailing Address: Shipping Address: P.O. Box 587 56 East Bell Drive Warsaw IN 46581-0587 Warsaw, IN 46582 Toll Free: 800 348 9500 Office: 574.267 6639 Main Fax: 574.267.8137 www.biomet.com
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Sports Medicine, Inc. % Ms. Elizabeth Wray Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
JUL 3 1 2007
Re: K071498
Trade/Device Name: Subtalar Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 30, 2007 Received: May 31, 2007
Dear Ms. Wray:
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.
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.
2
Page 2 -- Ms. Elizabeth Wray
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 vours.
Barbara Muchin
tor
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K071498
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
The Subtalar Implant is indicated for use in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, and medial displacement of the talus, thereby limiting the excessive eversion of the hindfoot. Examples include, but are not limited to:
- Symptomatic acquired flat foot treatment in children and adolescents .
- Symptomatic congenital flexible flat foot .
- Tarsal coalitions when associated with the flatfoot deformity .
- Posterior tibial tendon dysfunction with supple feet .
- Paralytic flat foot .
- Subtalar Instability .
- Severely pronated foot .
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buckner
Division Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Number K071498