(126 days)
Not Found
No
The description focuses on a mechanical bone staple and associated instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for "fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon," which aligns with the definition of a therapeutic device as it directly treats or alleviates a medical condition.
No
The device is a bone staple system used for fixation and reconstruction of bone and soft tissues, not for diagnosing medical conditions.
No
The device description explicitly states it is a "set, consisting of: 1. A bone staple. 2. Necessary surgical site sizing, preparation and insertion instruments (as a procedure pack)." These are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of bone fractures, bone reconstruction, ligament, soft tissue, and tendon. This is a surgical device used directly on the patient's body for structural support and repair.
- Device Description: The device consists of a bone staple and surgical instruments. These are physical implants and tools used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant and associated instruments.
N/A
Intended Use / Indications for Use
The Nextremity Solutions Arcus™ Staple System is indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon.
Examples include:
- ・ Fixation of bone fragments or small bones fractures
- . Fracture management in the foot and hand
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
The Nextremity Solutions Arcus™ Staple System is a set, consisting of:
-
- A bone staple.
-
- Necessary surgical site sizing, preparation and insertion instruments (as a procedure pack).
The staples are fabricated from medical grade Titanium (ASTM F-136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and hand
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)
Mechanical testing was performed as described in relevant recognized standards, including testing for 4 point bending (static and dynamic) and pull-out force for the Arcus™ Staple System as per ASTM F-564.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Z-Medical, Z-Guide Staple System (Marketed as Z-Staple) [510(k) K121277], Varisation Staple (Marketed as Varisation Staple) [510(k) K070033]
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/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 image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Nextremity Solutions, Incorporated Mr. Ryan Schlotterback Official Correspondent 54 Broad Street, Suite 200 Red Bank, New Jersey 07701
September 4, 2015
Re: K151160 Trade/Device Name: Arcus™ Staple System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: August 11, 2015 Received: August 12, 2015
Dear Mr. Schlotterback:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number: K151160
Device Name: Arcus™ Staple System
Indications For Use:
The Nextremity Solutions Arcus™ Staple System is indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon.
Examples include:
- ・ Fixation of bone fragments or small bones fractures
- . Fracture management in the foot and hand
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR Over-The-Counter Use
(Part 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)
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510(k) Summary (Per 21 CFR 807.92)
| General Company Information: | Nextremity Solutions, Inc.
Ryan Schlotterback
210 North Buffalo Street
Warsaw, IN 46580 |
|------------------------------|--------------------------------------------------------------------------------------------------|
| Date Prepared | August 11, 2015 |
General Device Information
| Product Name: | Arcus™ Staple System |
|---|---|
| Classification: | Single/multiple component metallic |
| bone fixation appliances and | |
| accessories | |
| 21 CFR 888.3030 | |
| Product code: JDR |
Predicate Devices
| Z-Medical, GmbH | Z-Medical, Z-Guide Staple System
(Marketed as Z-Staple)
[510(k) K121277] |
|------------------------|--------------------------------------------------------------------------------|
| Memometal Technologies | Varisation Staple
(Marketed as Varisation Staple)
[510(k) K070033] |
Description
The Nextremity Solutions Arcus™ Staple System is a set, consisting of:
-
- A bone staple.
-
- Necessary surgical site sizing, preparation and insertion instruments (as a procedure pack).
The staples are fabricated from medical grade Titanium (ASTM F-136).
4
Intended Use (Indications)
The Nextremity Solutions Arcus™ Staple System is indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon.
Examples include:
- Fixation of bone fragments or small bones fractures .
- . Fracture management in the foot and hand
Substantial Equivalence
The Nextremity Solutions, Arcus™ Staple System possesses the same technological characteristics as the predicate devices. These characteristics include the intended use, basic design, material, size and fundamental technology.
Performance Data
Mechanical testing was performed as described in relevant recognized standards, including testing for 4 point bending (static and dynamic) and pull-out force for the Arcus™ Staple System as per ASTM F-564.