(30 days)
No
The device description and summary of performance studies focus on the mechanical properties and design of a surgical plating system, with no mention of AI or ML capabilities.
Yes
The device is used for stabilization and fixation of a joint for surgical fusion, which is a therapeutic intervention.
No
This device is a plating system used for surgical fixation and stabilization of the first metatarsal-phalangeal joint, indicating it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description clearly outlines physical components (plates and screws) and associated instruments, indicating it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonumion or revision surgery." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details plates and screws, which are physical implants used in surgery.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is a surgical implant.
N/A
Intended Use / Indications for Use
The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonumion or revision surgery.
Product codes
HRS, HWC
Device Description
The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System consists of anatomically contoured, lowprofile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking Extremity Plating System (EPS) screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. Screws lengths are offered in 10-40mm for the 2.7mm diameter plate screws and in 10 – 60mm in 3.5mm and 4.0mm diameter plate screws. All components (implants and the associated instruments) are provided sterile and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first metatarsal-phalangeal joint in the foot
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)
Engineering analysis and rationale was completed to provide evidence that the modifications to system do not adversely affect the safety and effectiveness of the system components. The results of this analysis demonstrate substantial equivalence of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System to the predicate device.
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
March 26, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Gramercy Extremity Orthopedics, LLC % Tamala Wampler Regulatory Consultant Novus Management Group, LLC 4480 Lake Forest Drive. Ste. 412 Blue Ash, Ohio 45242
Re: K210534
Trade/Device Name: GEO FirstFUSE 1st MTP Joint Arthrodesis 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, HWC Dated: February 15, 2021 Received: February 24, 2021
Dear Tamala Wampler:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210534
Device Name
GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Indications for Use (Describe)
The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonumion or revision surgery.
| 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
Image /page/3/Picture/0 description: The image shows a logo for Gramercy Extremity Orthopedics. The logo has the letters GEO in green, yellow, and purple, respectively. Below the letters, the word "GRAMERCY" is written in gray, and below that, the words "EXTREMITY ORTHOPEDICS" are written in black.
GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System 510(k) Summary
| Submitted by/
Sponsor: | Gramercy Extremity
Orthopedics, LLC.
840 F. Avenue #104
Richardson, TX 75081
USA 972-908-9808 | | Contact Person: | Michael Simpson
CEO
855-436-2278 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|------------------|----------------------------------------|
| Date Prepared: | February 12, 2021 | | | |
| Trade Name: | GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System | | | |
| Common Name: | Plate, Fixation, Bone | | | |
| Classification Code
Name & Reference: | HRS | Plate, Fixation, Bone | 21 CFR §888.3030 | |
| | HWC | Screw, Fixation Bone | 21 CFR §888.3040 | |
| Predicate Devices | Primary Predicate Device: K200108 GEO 1st MTP Joint Arthrodesis Plating
System; Additional Predicate Device: K041287 Vilex Plating System | | | |
Device Description:
The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System consists of anatomically contoured, lowprofile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking Extremity Plating System (EPS) screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. Screws lengths are offered in 10-40mm for the 2.7mm diameter plate screws and in 10 – 60mm in 3.5mm and 4.0mm diameter plate screws. All components (implants and the associated instruments) are provided sterile and for single use only.
Indications for Use:
The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is indicated for use in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonunion, malunion or revision surgery.
Technological Characteristics:
The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System subject device has the same design and technological features as the cleared, commercially distributed predicate GEO 1st MTP Joint Arthrodesis Plating System (K200108). The additional screws lengths are equivalent to the screws lengths collectively offered by the primary predicate and the additional predicate, Vilex Plating System (K041287). The implant material remains unchanged. All patient contacting components are comprised of biocompatible materials. All System components are provided sterile by gamma radiation and are disposable, for single-use only.
Substantial Equivalence:
The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is substantially equivalent to the GEO 1st MTP Joint Arthrodesis Plating System cleared under K200108 and the Vilex Plating System cleared under K041287. The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System has the same intended use and material as the predicate(s) and the minor technological differences in plate and screw geometry (overall
4
plate and screw lengths, plate hole placement/configuration and angulation, and overall screw lengths) are not considered to raise new questions of safety or effectiveness.
Performance Data:
Engineering analysis and rationale was completed to provide evidence that the modifications to system do not adversely affect the safety and effectiveness of the system components. The results of this analysis demonstrate substantial equivalence of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System to the predicate device.
Conclusion:
The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is considered to be substantially equivalent to the predicate device. This conclusion is based on the similarities in principles of operation, technology, materials and intended use.