(28 days)
Not Found
No
The description focuses on the mechanical components and intended use of bone screws and associated instrumentation, with no mention of AI or ML capabilities.
Yes
The device is described as treating bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment, all of which are medical conditions or injuries that a therapeutic device would address.
No
This device is described as a "Bone Screw System" used for the fixation of malunion and nonunion, acute fractures, repetitive stress fractures, etc. It is a surgical implant designed for treatment, not for diagnosing conditions.
No
The device description explicitly states that the GEO Bone Screw System consists of physical components such as bone screws, washers, and instrumentation made of titanium alloy. It also mentions sterilization and single-use, which are characteristics of physical medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of bone fractures, osteotomies, arthrodesis, etc. These are all surgical procedures performed directly on the patient's body.
- Device Description: The device description details bone screws, washers, and surgical instrumentation. These are physical implants and tools used in surgery.
- 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 samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is an implantable surgical device used within the body.
N/A
Intended Use / Indications for Use
The GEO Bone Screw System is indicated for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment. Surgical indications include fixation of malunion and nonunion, acute fractures, repetitive stress fractures, malleolar, talus, and greater tuberosity fractures, Jones fracture and 5th metatarsal fracture fixation and bone reconstruction where appropriate for the size of the device.
Product codes
HWC, HTN
Device Description
The GEO Bone Screw System consists of sterile, stand-alone headed and headless, cannulated and solid, threaded bone screws, washers, and instrumentation. Bone screws are available in a variety of diameters and lengths including partially and fully threaded designs to accommodate application in varying bone sizes (for the Jones Fracture / 5th metatarsal procedures only the 4.0mm-6.5mm diameter screws are appropriate). Optional washers are available and sized to correspond with bone screws. K-wires and general, manual orthopedic instrumentation is provided and intended to facilitate implantation. Instrumentation includes wire quide handles. AO drive handles, drill bits, taps, depth gauges, countersinks, tissue protectors, hexalobe driver tips and screw diameter templates. GEO implants are comprised of titanium alloy. All implants are provided for single use only and sterilized by exposure to gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
No additional performance testing was required. The GEO Bone Screw System components have been subjected to design controls and previously tested to appropriate device-specific standards to support substantial equivalence, and validation to standards necessary to demonstrate the functionality of the device system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K161904, K153154, K190686, K191289, K180377
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Gramercy Extremity Orthopedics, LLC Michael Simpson CEO 1239 N. Glenville Dr. Richardson, Texas 75081
Re: K202817
Trade/Device Name: GEO Bone Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: August 31, 2020 Received: September 24, 2020
Dear Michael Simpson:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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) K202817
Device Name GEO Bone Screw System
Indications for Use (Describe)
The GEO Bone Screw System is indicated for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment. Surgical indications include fixation of malunion and nonunion, acute fractures, repetitive stress fractures, malleolar, talus, and greater tuberosity fractures, Jones fracture and 5th metatarsal fracture fixation and bone reconstruction where appropriate for the size of the device.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☑ Research Use (Part 21 CFR 321.3 Label D) ☐ Over-The-Counter Use (21 CFR 321.3 Label C) | ☑ Research Use (Part 21 CFR 321.3 Label D) | ☐ Over-The-Counter Use (21 CFR 321.3 Label C) |
| ☑ Research Use (Part 21 CFR 321.3 Label D) | ||
| ☐ Over-The-Counter Use (21 CFR 321.3 Label C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for Gramercy Extremity Orthopedics. The logo has the letters GEO in a horizontal line, with each letter in a different color. The G is green, the E is yellow, and the O is purple. Below the letters GEO, the word GRAMERCY is written in gray, and below that, the words EXTREMITY ORTHOPEDICS are written in gray.
| 510(k) Summary | ||||
|---|---|---|---|---|
| GEO Bone Screw System | ||||
| Submitted by: | Gramercy Extremity Orthopedics | Contact | ||
| Person: | Michael Simpson, CEO | |||
| 1239 N. Glenville Drive | 855-436-2278 | |||
| Richardson, TX 75081 | Date Prepared: | August 31, 2020 | ||
| Trade Name: | GEO Bone Screw System | |||
| Predicate | Primary Predicate Device (self): K161904 GEO Bone Screw System | |||
| Additional Predicate Devices: K153154 Stryker Asnis JFX System, K190686 | ||||
| Paragon 28 Monster Screw System, K191289 Vilex Bone Screw Line Addition, | ||||
| K180377 In2Bones Fracture and Correction System | ||||
| Common Names | Fixation, bone screw | Washer, Bolt Nut | ||
| Classification | ||||
| Names | Smooth or threaded metallic bone | |||
| fixation fastener | Single/Multiple, component metallic bone | |||
| fixation appliances & accessories | ||||
| Regulation: | 21 CFR 888.3040 | 21 CFR 888.3030 | ||
| Classification | II | II | ||
| Product Codes | HWC | HTN |
Device Description:
The GEO Bone Screw System consists of sterile, stand-alone headed and headless, cannulated and solid, threaded bone screws, washers, and instrumentation. Bone screws are available in a variety of diameters and lengths including partially and fully threaded designs to accommodate application in varying bone sizes (for the Jones Fracture / 5th metatarsal procedures only the 4.0mm-6.5mm diameter screws are appropriate). Optional washers are available and sized to correspond with bone screws. K-wires and general, manual orthopedic instrumentation is provided and intended to facilitate implantation. Instrumentation includes wire quide handles. AO drive handles, drill bits, taps, depth gauges, countersinks, tissue protectors, hexalobe driver tips and screw diameter templates. GEO implants are comprised of titanium alloy. All implants are provided for single use only and sterilized by exposure to gamma irradiation.
Indications for Use:
The GEO Bone Screw System is indicated for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment. Surgical indications include fixation of malunion and nonunion, acute fractures, repetitive stress fractures, malleolar, talus, and greater tuberosity fractures, Jones fracture and 5th metatarsal fracture fixation and bone reconstruction where appropriate for the size of the device.
Technical Comparison & Equivalence:
The GEO Bone Screw System subject device has the same design and technological features as the cleared, commercially distributed predicate GEO Bone Screw System (K161904). The labeling has been revised to include examples of surgical indications within the cleared intended use of the device. No new questions of safety and effectiveness are raised by this modification.
Performance Data:
No additional performance testing was required. The GEO Bone Screw System components have been subjected to design controls and previously tested to appropriate device-specific standards to support substantial equivalence, and validation to standards necessary to demonstrate the functionality of the device system.
4
Summary: The GEO Bone Screw System described herein is substantially equivalent to the predicate device (original GEO Bone Screw System) based upon the intended use, technological characteristics.
Conclusion
The GEO Bone Screw System with revised indications for use is substantially equivalent to the predicate device.