GEO Bone Screw System

K202817 · Gramercy Extremity Orthopedics, LLC · HWC · Oct 22, 2020 · Orthopedic

Device Facts

• Record ID: K202817
• Device Name: GEO Bone Screw System
• Applicant: Gramercy Extremity Orthopedics, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Oct 22, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

GEO Bone Screw System comprises sterile, single-use, headed/headless, cannulated/solid threaded titanium alloy bone screws and washers; includes manual orthopedic instrumentation (K-wires, drill bits, taps, depth gauges, countersinks, drivers). Used by surgeons in clinical settings for bone fixation and reconstruction. Implants provide mechanical stabilization of bone segments; instrumentation facilitates implantation. System is intended for surgical procedures involving fractures, osteotomies, and arthrodesis. Benefits include stabilization of bone to promote healing.

Clinical Evidence

No clinical data. Bench testing only; components previously subjected to design controls and tested to device-specific standards to support substantial equivalence.

Technological Characteristics

Materials: Titanium alloy. Components: Headed/headless, cannulated/solid threaded screws, washers. Instrumentation: Manual orthopedic tools (K-wires, drill bits, taps, depth gauges, countersinks, drivers). Sterilization: Gamma irradiation. Single-use only.

Indications for Use

Indicated for patients requiring bone fixation for fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment. Specific applications include malunion, nonunion, acute fractures, repetitive stress fractures, malleolar, talus, greater tuberosity, Jones, and 5th metatarsal fractures, and bone reconstruction.

Regulatory Classification

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.

Predicate Devices

• GEO Bone Screw System (K161904)
• Stryker Asnis JFX System (K153154)
• Paragon 28 Monster Screw System (K190686)
• Vilex Bone Screw Line Addition (K191289)
• In2Bones Fracture and Correction System (K180377)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| <table style="border: none;"><tr><td><span style="font-size: 20px;"> ☑ </span> Research Use (Part 21 CFR 321.3 Label D)</td></tr><tr><td><span style="font-size: 20px;"> ☐ </span> Over-The-Counter Use (21 CFR 321.3 Label C)</td></tr></table> | <span style="font-size: 20px;"> ☑ </span> Research Use (Part 21 CFR 321.3 Label D) | <span style="font-size: 20px;"> ☐ </span> Over-The-Counter Use (21 CFR 321.3 Label C) |
| <span style="font-size: 20px;"> ☑ </span> Research Use (Part 21 CFR 321.3 Label D) | | |
| <span style="font-size: 20px;"> ☐ </span> 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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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<br>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<br>Names | Smooth or threaded metallic bone<br>fixation fastener | | Single/Multiple, component metallic bone<br>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.

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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.