(134 days)
Not Found
No
The summary describes a mechanical fixation system (staple and screws) and mentions only mechanical testing, with no indication of software, image processing, or AI/ML components.
No
The device is described as a fixation system for alignment, stabilization, and fusion of small bones (e.g., foot and ankle), which are structural repairs rather than therapeutic treatments.
No
The device is a fixation system used for surgical alignment, stabilization, and fusion, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it consists of a compression staple, screws, and surgical instruments, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle." This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The description details a "compression staple and two non-locking cortical screws" made from medical grade stainless steel. These are physical implants, not reagents, instruments, or systems used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used to fix bones.
N/A
Intended Use / Indications for Use
The Restore™ Fixation System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.
Product codes
JDR, HRS, HWC
Device Description
The Restore™ Fixation System consists of a compression staple and two non-locking cortical screws (one for optional use) with surgical site preparation and insertion instruments. The compression staple and cortical screw are fabricated from medical grade stainless steel alloy (ASTM F-139 and F-138) and are pre-packaged sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones such as the foot and ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 compression staple per ASTM F-564 and torque to failure and pull-out force for the non-locking cortical screw per ASTM F-543.
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
§ 888.3030 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
510(k) Summary (Per 21 CFR 807.92)
General Company Information:
Nextremity Solutions, Inc. Jorge A. Montoya Director, Product Development 60 Broad Street, Suite 102 Red Bank, NJ 07701 Phone: (732) 383-7984 Fax: (732) 865-7632
AUG 2 8 2013
Date Prepared
May 29, 2013
General Device Information
Product Name:
Classification:
Restore™ Fixation System
Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030 Product codes: JDR (staple fixation, bone) and HRS (plate fixation, bone)
Smooth or threaded metallic bone fixation fastener and accessories 21 CFR 888.3040 Product code: HWC (screw, fixation, bone)
Class II device
Predicate Devices
Z-Medical GmbH &Co. KG
Arthrex Inc.
Biomet Trauma
Z-Guide Staple (Marketed as Z-Medical Staple) [510(k) K121277]
Arthrex Low Profile Screw (Marketed as Arthrex Low Profile Screw) [510(k) K103705]
BioDrive™ Micro Screw System (Marketed as BioDrive™ Micro Nail Plate/Screw) [510(k) K092670]
1
Description
The Restore™ Fixation System consists of a compression staple and two non-locking cortical screws (one for optional use) with surgical site preparation and insertion instruments. The compression staple and cortical screw are fabricated from medical grade stainless steel alloy (ASTM F-139 and F-138) and are pre-packaged sterile.
Intended Use (Indications)
The Restore™ Fixation System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.
Substantial Equivalence
The Restore™ Fixation System possesses the same indication and technological characteristics (basic design, material, size and fundamental technology) of the predicate devices.
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 compression staple per ASTM F-564 and torque to failure and pull-out force for the non-locking cortical screw per ASTM F-543.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure 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 emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2013
Mr. Jorge A. Montoya Director, Product Development Nextremity Solutions, Incorporated 60 Broad Street, Suite 102 Red Bank, New Jersey 07701
Re: K131061
Trade/Device Name: Restore™ Fixation 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, HRS, HWC Dated: May 29, 2013 Received: May 30, 2013
Dear Mr. Montoya:
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. Jorge A. Montoya
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.goy/MedicalDevices/Safety/ReportaProblem/deliault.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K131061
Device Name: Restore™ Fixation System
Indications For Use:
The Restore™ Fixation System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Elizabeth L. Frank -S
Division of Orthopedic Devices