(104 days)
Not Found
No
The document describes a mechanical implant and does not mention any AI or ML components or functionalities.
Yes.
The device is intended to treat a hyperpronated foot and addresses specific medical conditions such as flat foot, indicating a therapeutic purpose.
No
This device, an Arthrex Subtalar (Arthroeresis) Implant, is described as an implantable device intended to assist in treating a hyperpronated foot by stabilizing the subtalar joint. Its purpose is therapeutic (blocking displacement, limiting eversion), not diagnostic.
No
The device description explicitly states it is comprised of "titanium alloy implants," indicating a physical hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to stabilize a joint within the human body to treat a physical condition (hyperpronated foot). This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a titanium alloy implant, which is a physical device implanted into the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the body.
- No mention of in vitro testing: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing tests outside of the body.
IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device is used to treat a condition by physically altering the structure of the foot.
N/A
Intended Use / Indications for Use
The Arthrex Subtalar (Arthoeresis) Implant is intended to assist in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, downward, and medial displacement of the talus thereby limiting excessive eversion of the hindfoot.
Examples include:
- . Symptomatic acquired flat foot treatment in children and adolescents
- Symptomatic congenital flexible flat foot .
- ♥ Tarsal coalitions when associated with a flatfoot deformity
- Posterior tibial tendon dysfunction with supple feet ◆
- Paralytic flat foot ♥
Product codes
HWC
Device Description
The Arthrex Arthroeresis Family is currently comprised of titanium allov implants according to ASTM F-136. They are offered in several different sizes. They are offered sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot, subtalar joint
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K960692, K001231, K042030, K031155
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.
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510(k) Summary
| 510(k) Number: | K053543 |
|---|---|
| Company: | Arthrex, Inc. |
| Address: | 1370 Creekside Blvd., Naples, FL 34108-1945 |
| Telephone: | (239) 643-5553 |
| Facsimile: | (239) 598-5508 |
| Contact: | Ann Waterhouse |
| Device Name: | Arthrex Arthroeresis Family |
| Classification: | Screw, Fixation, Bone |
| Product Code: | HWC |
Predicate Devices: K960692, MBA Subtalar by KMI, K001231, Kalix Implant by New Deal, K042030, HyProCure Subtalar Implant system by Graham Medical Technologies, LLC, and the OsteoMed Subtalar Implant by Osteomed, K031155.
Description:
The Arthrex Arthroeresis Family is currently comprised of titanium allov implants according to ASTM F-136. They are offered in several different sizes. They are offered sterile.
Indications for Use:
The Arthrex Subtalar (Arthoeresis) Implant is intended to assist in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, downward, and medial displacement of the talus thereby limiting excessive eversion of the hindfoot.
Examples include:
- . Symptomatic acquired flat foot treatment in children and adolescents
- Symptomatic congenital flexible flat foot .
- ♥ Tarsal coalitions when associated with a flatfoot deformity
- Posterior tibial tendon dysfunction with supple feet ◆
- Paralytic flat foot ♥
Technical Differences:
The basis for substantial equivalence is in supporting the use of your device in the same manner as that of a competitor. The above listed predicate devices have been tested against the Arthrex Arthroeresis Implant and per enclosed testing, outperform or meet the parameters set by Arthrex competitors.
1
Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device for the previously cleared indications for use. The Arthroeresis Family of Implants does not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials used in construction of these devices are well characterized and have been used in predicate devices with similar indications.
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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 (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The caduceus is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2006 APR
Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K053543
Trade/Device Name: Arthroeresis Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HWC Dated: March 20, 2006 Received: March 21, 2006
Dear Ms. Waterhouse:
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
3
Page 2 - Ms. Ann Waterhouse, RAC
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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hubert Humphrey
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K053543
Device Name: Arthrex Arthroeresis Implant
Indications for Use:
The Arthrex Subtalar (Arthoeresis) Implant is intended to assist in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, downward, and medial displacement of the talus thereby limiting excessive eversion of the hindfoot
Examples include:
- Symptomatic acquired flat foot treatment in children and adolescents .
- Symptomatic congenital flexible flat foot .
- Tarsal coalitions when associated with a flatfoot deformity .
- Posterior tibial tendon dysfunction with supple feet .
- Paralytic flat foot .
Prescription Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over
(21
Over-The-Counter Use (21 CFR 801 Subpart C')
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1_ of _ of _ _
Hubert Lemonds
Division of General, Restorative, and Neurological Devices
510(k) Number K053543