(94 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and materials of the plating system, with no mention of software, algorithms, or data processing related to AI/ML.
No.
The device is a plate and screw construct for fixation of fractures, osteotomies, non-unions, and fusions, which are surgical interventions rather than therapeutic treatments.
No
The device is a surgical plating system (plate and screws construct) used for fixation of fractures, osteotomies, non-unions, and fusions of small bones. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a "plate and screws construct" and includes physical components like plates, screws, and instruments, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "fixation of fractures, osteotomies, non-unions and fusions of small bones and small bone segments". This describes a surgical implant used in the body to provide structural support and stability to bone.
- Device Description: The description details plates, screws, and surgical instruments used for bone fixation. These are physical devices implanted during surgery.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The information provided consistently points to this being a surgical implant system, not an IVD.
N/A
Intended Use / Indications for Use
The Nextremity Solutions Stratum™ Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, non-unions and fusions of small bones and small bone segments, particularly in osteopenic bone.
Product codes
HRS, HWC
Device Description
The Stratum™ Foot Plating System is a foot and ankle plating system consisting of plate and screw implants. The plates range in length from 26mm to 81.5mm and in width from 8.5mm to 29mm and feature between 2 and 10 screw holes. There are 6 different styles of screws; 2 diameters of nonlocking screw, 3 diameters of fixed angle locking screws and 1 diameter of multi-directional locking screw. The screws range in length from 10mm to 70mm. Screws are available in sterile and non-sterile versions. The system also includes a sterile set of accessory instruments and individually packaged drill guides / drill bits designed for preparation of the implant site and insertion of devices into the bone. The plates, sterile screws, instrument kits, and drill guide / drill bits are all packaged individually in separate sterile packaging. The non-sterile screws are provided in a case and tray suitable for steam sterilization. The plates, non-locking and locking screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The multi-directional locking screws are manufactured from Co-Cr-Mo conforming to ASTM F75.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle, small bones and small bone segments
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)
To evaluate the strength of the Stratum™ Foot Plating System worst case plates were tested in static and dynamic four point bending with two different gap widths according to ASTM F382-99 and worst case screws were torqued to failure according to ASTM F543-13. These tests confirmed that the strength of the worst case Stratum plates and screws is substantially equivalent to predicate devices with similar indications and is adequate for their intended use. Bacterial Endotoxin Testing using the LAL method was performed and confirmed endotoxin levels of
§ 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/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
Nextremity Solutions, Inc. Adam Finley Assoc. Director, Product Development 210 North Buffalo Street Warsaw, Indiana 46580
November 16, 2018
Re: K182201
Trade/Device Name: Stratum Foot Plating 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 Dated: October 20, 2018 Received: October 23, 2018
Dear Adam Finley:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/7 description: The image shows a digital signature. The name "Jesse Muir -S" is prominently displayed on the left side of the image. On the right side, the text "Digitally signed by Jesse Muir -S Date: 2018.11.16 10:34:56 -05'00'" is displayed.
For. Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182201
Device Name
Stratum™ Foot Plating System
Indications for Use (Describe)
The Nextremity Solutions Stratum™ Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, non-unions and fusions of small bones and small bone segments, particularly in osteopenic bone.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| 510(k) Summary | |
|---|---|
| Prepared: | October 12, 2018 |
| Submitter: | Nextremity Solutions, Inc. |
| 210 North Buffalo Street | |
| Warsaw, IN 46580 | |
| Contact: | Adam Finley |
| Assoc. Director, Product Development | |
| Adam.Finley@Nextremity.com | |
| Phone: 574-807-6150 | |
| Proprietary Name: | Stratum™ Foot Plating System |
| Common Name: | Bone Plate System |
| Classifications: | 21 CFR §888.3030: Single/Multiple Component Metallic Bone Fixation |
| Fastener Appliances and Accessories; Class II | |
| 21 CFR §888.3040: Smooth or Threaded Metallic Bone Fixation Fastener; | |
| Class II | |
| Product Codes: | 87/HRS, 87/HWC |
| Substantially | |
| Equivalent Devices: | • Synthes, Inc. Modular Mini Fragment LCP System, K063049 |
| • Nextremity Solutions MSP Metatarsal Shortening System, K140724 | |
| • Biomet A.L.P.S. Small Bone Locked Plating System, K131670 |
Device Description:
The Stratum™ Foot Plating System is a foot and ankle plating system consisting of plate and screw implants. The plates range in length from 26mm to 81.5mm and in width from 8.5mm to 29mm and feature between 2 and 10 screw holes. There are 6 different styles of screws; 2 diameters of nonlocking screw, 3 diameters of fixed angle locking screws and 1 diameter of multi-directional locking screw. The screws range in length from 10mm to 70mm. Screws are available in sterile and non-sterile versions. The system also includes a sterile set of accessory instruments and individually packaged drill guides / drill bits designed for preparation of the implant site and insertion of devices into the bone. The plates, sterile screws, instrument kits, and drill guide / drill bits are all packaged individually in
4
separate sterile packaging. The non-sterile screws are provided in a case and tray suitable for steam sterilization. The plates, non-locking and locking screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The multi-directional locking screws are manufactured from Co-Cr-Mo conforming to ASTM F75.
Indications:
The Nextremity Solutions Stratum™ Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, non-unions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.
Summary of Technologies/Substantial Equivalence:
The Stratum Plate System is substantially equivalent to the predicate devices in regards to its intended use and indications, materials, designs, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise different questions of safety and effectiveness.
Non-Clinical Testing:
To evaluate the strength of the Stratum™ Foot Plating System worst case plates were tested in static and dynamic four point bending with two different gap widths according to ASTM F382-99 and worst case screws were torqued to failure according to ASTM F543-13. These tests confirmed that the strength of the worst case Stratum plates and screws is substantially equivalent to predicate devices with similar indications and is adequate for their intended use. Bacterial Endotoxin Testing using the LAL method was performed and confirmed endotoxin levels of