(134 days)
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.
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.
Here's an analysis of the provided information regarding the acceptance criteria and study for the Restore™ Fixation System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details mechanical testing performed to demonstrate substantial equivalence, rather than specific acceptance criteria with pass/fail values. The "Performance Data" section states that testing was done "as described in relevant recognized standards." Without the specific standards or their defined criteria and the numerical results, a precise table with acceptance criteria is not possible. However, based on the general information, we can infer the tested parameters.
| Acceptance Criteria (Inferred from Standards) | Reported Device Performance |
|---|---|
| Compression Staple (per ASTM F-564): | |
| 4-point bending (static) performance | Mechanical testing performed; device met performance described in ASTM F-564 for 4-point bending (static). (Specific numerical results not provided in this summary.) |
| 4-point bending (dynamic) performance | Mechanical testing performed; device met performance described in ASTM F-564 for 4-point bending (dynamic). (Specific numerical results not provided in this summary.) |
| Pull-out force performance | Mechanical testing performed; device met performance described in ASTM F-564 for pull-out force. (Specific numerical results not provided in this summary.) |
| Non-locking Cortical Screw (per ASTM F-543): | |
| Torque to failure performance | Mechanical testing performed; device met performance described in ASTM F-543 for torque to failure. (Specific numerical results not provided in this summary.) |
| Pull-out force performance | Mechanical testing performed; device met performance described in ASTM F-543 for pull-out force. (Specific numerical results not provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of devices or tests) used for the mechanical testing. "Mechanical testing was performed" is a general statement.
- Data Provenance: The data is from mechanical testing performed on the device components (compression staple and non-locking cortical screw). It is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in the human clinical sense. The testing would have been conducted by the manufacturer or a contracted lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is mechanical performance testing of a medical device, not a human clinical study requiring expert assessment of ground truth. The "ground truth" here is compliance with established mechanical engineering standards.
4. Adjudication Method for the Test Set
This is not applicable to mechanical testing. Adjudication methods (like 2+1, 3+1) are used for clinical studies where multiple experts interpret data to establish a consensus ground truth. For mechanical testing, adherence to a standard protocol and measurement accuracy are the primary concerns.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. The device described is a physical orthopedic fixation system (staple and screws), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical fixation system, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical performance testing was established mechanical engineering standards:
- ASTM F-564 for the compression staple.
- ASTM F-543 for the non-locking cortical screw.
The device's performance was evaluated against the requirements and methodologies outlined in these recognized standards.
8. The Sample Size for the Training Set
This is not applicable as the testing described is mechanical performance evaluation of a medical device, not the training of an algorithmic model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" in the context of this mechanical performance study.
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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]
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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.
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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
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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
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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
§ 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.