(237 days)
Not Found
No
The summary describes a mechanical implant (screw) and makes no mention of software, algorithms, or any AI/ML related terms.
Yes
The device is an implant used to provide structural support during healing after primary surgical interventions for flat foot, which fits the definition of a therapeutic device.
No
Explanation: This device is an arthroereisis subtalar implant, which is a surgical implant designed to provide structural support for flat foot treatment. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is a "fully threaded, cannulated, tapered screw," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "internal support to primary surgical interventions in the treatment of flat foot, providing structural support". This describes a surgical implant used within the body to provide mechanical support.
- Device Description: The description confirms it's a "fully threaded, cannulated, tapered screw". This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve tests on blood, urine, tissue samples, etc.
Therefore, the Arthrex ProStop™ Plus Arthroereisis Subtalar Implant is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex ProStop™ Plus Arthroereisis Subtalar Implants are indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing.
Product codes
HWC, MAI
Device Description
The Arthrex ProStop™ Plus Arthroereisis Subtalar Implant is a fully threaded, cannulated, tapered screw. It is similar in design to the predicate device MBA Resorb Implant, K051611.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
4 510(k) Summary of Safety and Effectiveness
| Manufacturer/Sponsor | Arthrex, Inc.1370 Creekside Boulevard Naples, Florida 34108-1945 |
|---|---|
| 510(k) Contact | Mariela Cabarcas |
| Regulatory Affairs Associate | |
| Telephone: 239/643.5553, ext. 1246 | |
| Fax: 239/598.5508 | |
| Email: mcabarcas@arthrex.com | |
| JAN 17 2008 | |
| Trade Name | Arthrex ProStop Plus™ Arthroereisis Subtalar Implant |
| Common Name | Screw, Fixation, Bone |
| Product Code - | |
| Classification Name | HWC -Screw, Fixation, Bone |
| Predicate Device | MBA Resorb Implant: K051611 |
| Device Description | |
| and Intended Use | The Arthrex ProStop™ Plus Arthroereisis Subtalar Implant is a fully |
| threaded, cannulated, tapered screw. It is similar in design to the predicate | |
| device MBA Resorb Implant, K051611. | |
| The Arthrex ProStop™ Plus Arthroereisis Subtalar Implants are | |
| indicated as an internal support to primary surgical interventions in the | |
| treatment of flat foot, providing structural support at minimum during the first | |
| three months of healing. | |
| Substantial | |
| Equivalence Summary | The Arthrex ProStop™ Plus Arthroereisis Subtalar Implant is |
| substantially equivalent to the predicate the predicate device MBA Resorb | |
| Implant, K051611, in which the basic features and intended uses are the | |
| same. Any differences between the ProStop™ Plus Arthroereisis Subtalar | |
| Implant and the predicate K051611 are considered minor and do not raise | |
| questions concerning safety and effectiveness. Based on the information | |
| submitted, Arthrex, Inc. has determined that the new ProStop™ Plus | |
| Arthroereisis Subtalar Implant is substantially equivalent to the currently | |
| marketed predicate device. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2008
Arthrex, Inc. % Ms. Mariela Cabarcas Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K071456
Trade/Device Name: ProStop Plus Arthroereisis Subtalar Implant Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI, HWC Dated: January 9, 2008 Received: January 10, 2008
Dear Ms. Cabarcas:
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
2
Page 2 – Ms. Mariela Cabarcas
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 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Mullen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
3 Indications for Use Form
Indications for Use
510(k) Number:
Device Name:
Arthrex ProStop™ Plus Arthroereisis Subtalar Implant
The Arthrex ProStop™ Plus Arthroereisis Subtalar Implants are indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing.
Prescription Use _ X_ AND/OR Over-The-Counter Use _ (Per 21 CFR 801 Subpart D) (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)
PAGE 1 of 1
harbare Buehus
Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number K071456