(54 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical hardware, with no mention of AI/ML terms or functionalities.
No
The device is indicated for fixation of fractures, osteotomies, nonunions, malunions, and fusions of small bones, which are structural repairs rather than therapeutic treatments that alleviate or cure a disease or condition.
No.
The device is a system for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and segments. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components such as bone plates, screws, and surgical instruments, all made of Titanium. There is no mention of software as a component of this system.
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 "fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments." This describes a surgical implant used to treat physical conditions within the body.
- Device Description: The device is described as a "bone plate," "cortical and locking screws," and "surgical site preparation and insertion instruments." These are all physical components used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Nextremity Solutions MSP™ System is indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone. Examples include, but not limited to, the hand, foot (shortening of the lesser metatarsal) and ankle.
Product codes
HRS, HWC
Device Description
The Nextremity Solutions MSP™ Metatarsal Shortening System is a set, consisting of:
-
- A bone plate.
-
- Specific length, cortical and locking screws.
- Necessary surgical site preparation and insertion instruments (as a procedure pack). 3.
The cortical and locking screw(s) are used in conjunction with the bone plate and are individually packaged.
The plate and screws are fabricated from medical grade Titanium and the design allows for fixation of fractures, osteotomies, non-unions, malunions and fusions of small bones and small bone segments found in the foot, particularly in osteopenic bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, foot (shortening of the lesser metatarsal) and ankle.
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 4 point bending (static and dynamic) for the MSP plate per ASTM F-382 and torque to failure for the screws per ASTM F-543. An axial push-out test was implemented to properly compare the predicate device to the proposed MSP screw designs given the short length of the socies.
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
MAY 1 4 2014
K140724 page 1 of 2
510(k) Summary (Per 21 CFR 807.92)
General Company Information:
Nextremity Solutions, Inc. Jorge A. Montoya Director, Product Development 54 Broad Street, Suite 200 Red Bank, NJ 07701 Phone: (732) 383-7901 Fax: (732) 865-7632
Date Prepared
February 20, 2014
General Device Information
Product Name:
Classification:
MSPTM Metatarsal Shortening System
Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030 Product code: HRS
Smooth or Threaded metallic bone fixation fastener and accessories 21 CFR 888.3040 Product code: HWC Class II device
Predicate Devices
Synthes, Inc.
Modular Mini Fragment LCP System (Marketed as Modular Mini Fragment LCP System) [510(k) K063049]
Description
The Nextremity Solutions MSP™ Metatarsal Shortening System is a set, consisting of:
-
- A bone plate.
-
- Specific length, cortical and locking screws.
- Necessary surgical site preparation and insertion instruments (as a procedure pack). 3.
The cortical and locking screw(s) are used in conjunction with the bone plate and are individually packaged.
1
The plate and screws are fabricated from medical grade Titanium and the design allows for fixation of fractures, osteotomies, non-unions, malunions and fusions of small bones and small bone segments found in the foot, particularly in osteopenic bone.
Intended Use (Indications)
The Nextremity Solutions MSP™ System is indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone. Examples include, but not limited to, the hand, foot (shortening of the lesser metatarsal) and ankle.
Substantial Equivalence
The Nextremity Solutions, MSP™ Metatarsal Shortening System possesses the same technological characteristics of 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 4 point bending (static and dynamic) for the MSP plate per ASTM F-382 and torque to failure for the screws per ASTM F-543. An axial push-out test was implemented to properly compare the predicate device to the proposed MSP screw designs given the short length of the socies.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure embracing another figure. The symbol is composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G66 Silver Spring, MD 20993-0002
May 14, 2014
Nextremity Solutions, Incorporated Mr. Jorge A. Montoya Director, Product Development 54 Broad Street, Suite 200 Red Bank, New Jersey 07701
Re: K140724
Trade/Device Name: MSP™ Metatarsal Shortening System Regulation Number: 21 CFR 888.3030 Regulation Name: Single multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: March 27, 2014 Received: March 28, 2014
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Jorge A. Montoya
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 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/dcfault.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.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K140724 page 1 of 1
Indications for Use Statement
510(k) Number (if known); K140724
Device Name: MSPTM Metatarsal Shortening System
Indications For Use:
The Nextremity Solutions MSP™ System is indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone. Examples include, but not limited to, the hand, foot (shortening of the lesser metatarsal) 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鼎ank -S
Division of Orthopedic Devices