(191 days)
Not Found
No
The summary describes a mechanical bone screw system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, the GEO Bone Screw System, is indicated for treating medical conditions such as bone fractures, arthrodesis, osteochondritis, and tendon reattachment, which directly address a disease or condition.
No
The device is described as an implant used for treating bone fractures and other related conditions, not for diagnosing them.
No
The device description explicitly states that the device includes physical implants (bone screws, washers, k-wires) and general orthopedic instruments, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The GEO Bone Screw System is an implantable device used to fix bone fractures and perform other orthopedic procedures within the body.
- Intended Use: The intended use is for surgical procedures involving bone, not for analyzing biological samples.
The information provided clearly describes a surgical implant, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The GEO Bone Screw System is indicated for bone fractures, arthrodesis, osteochondritis, and tendon reattachment.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
The GEO Bone Screw System implants include cannulated and solid, low-profile headed and headless, partial and fully threaded bone screws in a variety of diameters and lengths. Optional washers, correspondingly sized to each bone screw, are available as well as k-wires and general orthopedic instruments. GEO implants are comprised of titanium alloy. The GEO Bone Screw System is provided sterile 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)
An engineering analysis was performed for torsional strength and pullout strength for worst case GEO bone screws and comparable worst case predicate bone screws. This analysis showed the GEO Bone Screw results to be equivalent or better than that of the predicate. Pyrogenicity (LAL) testing was conducted on worst case bone screw/washers using the gel-clot method. The results from the pyrogen testing show the EU levels below the limit. Based on these data, the GEO Bone Screws have the design, geometry and mechanical properties suitable for performing its intended use. No clinical performance data were needed to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K991151/K991197, K042310, K143460, K150693
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Gramercy Extremity Orthopedics, LLC Ms. Mary Biggers Regulatory Affairs 1239 N. Glenville Drive Richardson, Texas 75081
January 18, 2017
Re: K161904
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: December 8, 2016 Received: December 12, 2016
Dear Ms. Mary Biggers:
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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
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 and Part 809), 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/default.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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161904
Device Name
GEO BONE SCREW SYSTEM
Indications for Use (Describe)
The GEO Bone Screw System is indicated for bone fractures, arthrodesis, osteochondritis, and tendon reattachment.
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)
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Image /page/3/Picture/0 description: The image shows the logo for GEO Gramercy Extremity Orthopedics. The logo has a purple vertical bar on the left, followed by the letters GEO in green, yellow, and purple. Below the letters are the words "GRAMERCY EXTREMITY ORTHOPEDICS" in gray and black.
| Submitted by: | Gramercy Extremity Orthopedics, LLC
1239 N. Glenville Drive
Richardson, Texas 75081
855-436-2278 | |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Date Prepared: | January 17, 2017 | |
| Contact Person: | Mary Biggers
Regulatory Affairs
855-436-2278 | |
| Trade Name:
Common Names:
Classification Names: | GEO Bone Screw System
Fixation bone screw
Smooth or threaded metallic
bone fixation fastener | Washer, Bolt Nut
Single/multiple, component
metallic bone fixation
appliances & accessories |
| References:
Product Codes: | 21 CFR § 888.3040 – Class II
HWC | 21 CFR § 888.3030 - Class II
HTN |
| Primary Predicate | K991151/K991197: Cannulated Screws (Vilex) | |
| Additional Predicates | K042310: Cannulated Bone Screws (OrthoPro)
K143460: Cannulated Screw System (Wright Medical)
K150693: PHIN-FX Cannulated Lag Screw System (Ascent
Medical, LLC.) | |
| Device Description: | The GEO Bone Screw System implants include cannulated and
solid, low-profile headed and headless, partial and fully threaded
bone screws in a variety of diameters and lengths. Optional
washers, correspondingly sized to each bone screw, are available
as well as k-wires and general orthopedic instruments. GEO
implants are comprised of titanium alloy. The GEO Bone Screw
System is provided sterile by exposure to gamma irradiation. | |
| Indications for Use: | The GEO Bone Screw System is indicated for bone fractures,
osteotomies, arthrodesis, osteochondritis, and tendon
reattachment. | |
| Technological
Comparison: | The GEO Screw System has similar technical characteristics
including indications for use, dimensions of diameter and length,
material (titanium alloy) and basic design (threaded, cannulated
and solid, self tapping, self drilling) as the legally marketed
predicate devices. | |
| Performance Data: | An engineering analysis was performed for torsional strength and
pullout strength for worst case GEO bone screws and comparable
worst case predicate bone screws. This analysis showed the GEO
Bone Screw results to be equivalent or better than that of the
predicate. Pyrogenicity (LAL) testing was conducted on worst case
bone screw/washers using the gel-clot method. The results from
the pyrogen testing show the EU levels below the limit. Based on
these data, the GEO Bone Screws have the design, geometry and
mechanical properties suitable for performing its intended use.
No clinical performance data were needed to support substantial
equivalence. | |
| Summary: | The GEO Bone Screw System is substantially equivalent to the
predicate devices based upon the indication for use, technological
characteristics, and the data submitted. | |
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Image /page/4/Picture/0 description: The image is a logo for Gramercy Extremity Orthopedics. The logo has a purple vertical bar on the left side. To the right of the bar are the letters GEO in green, yellow, and purple. Below the letters are the words GRAMERCY EXTREMITY ORTHOPEDICS in gray and black.