(61 days)
Not Found
No
The device description and performance studies section do not mention any AI or ML components or capabilities. The device is a set of standard bone fixation fasteners.
No.
The device is used for fixation of bone fractures and reconstruction, acting as a mechanical aid rather than providing therapy itself.
No
The device is indicated for fixation of bone fractures, bone reconstructions, and as guide pins, which are therapeutic and procedural uses, not diagnostic.
No
The device description explicitly states that the device consists of physical components (Kirschner wires, Steinmann pins, and bone screws) made of stainless steel. This is a hardware medical device, not software-only.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes the GSO Bone Fixation Fasteners as physical implants (wires, pins, and screws) made of stainless steel, intended for the mechanical fixation of bone fractures and reconstructions. They are used within the body to stabilize bone.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples, detect biomarkers, or provide any diagnostic information about a patient's health status.
Therefore, based on the provided information, the GSO Bone Fixation Fasteners are a type of orthopedic implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GSO Bone Fixation Fasteners are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Warning: GSO Bone Fixation Devices are not indicated for spinal fixation.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The GSO Bone Fixation Fasteners consist of sterile and non-sterile, single-use, smooth and threaded Kirschner wires and Steinmann pins (ranging in length from 4 to 12 inches and in diameter from 0.028 to 0.177 inches), and cortical, cancellous, and malleolar bone screws (ranging in length from 6 to 160 mm and in screw diameter from 1.5 to 6.5mm). All GSO Bone Fixation Fasteners are manufactured from 316-LVM stainless steel conforming to standard ASTM-F138.
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)
Non-clinical testing was not necessary to determine substantial equivalence between the GSO Bone Fixation Fasteners and the predicates.
Clinical testing was not necessary to determine substantial equivalence between the GSO Bone Fixation Fasteners and the predicates.
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.
K960385, K011719, K972403, K061620, K023260
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.
0
3. 510(K) SUMMARY
| 1. Applicant/Sponsor: | Gold Standard Orthopaedics, LLC. | ||
|---|---|---|---|
| 1226 Rowan St. | |||
| Louisville, KY 40203 | |||
| 2. Contact Person: | David Baughman | ||
| President | |||
| David06@Baughmangroup.com | |||
| Phone (502) 581-8770 | JAN 3 1 200 | ||
| 3. Proprietary Name: | GSO Bone Fixation Fasteners | ||
| 4. Common Name: | Bone Fixation Fasteners | ||
| 5. Classification Name: | Smooth or threaded metallic bone fixation fastener | ||
| (21 CFR 888.3040) |
- Legally Marketed Devices to which Substantial Equivalence is claimed:
- . Sterile Kirschner Wires and Steinmann Pins - DePuy, Inc. (K960385)
- PLUS Cancellous Bone Screws Plus Orthopedics (K011719) ●
- BTI Cortical Bone Screws Biodynamic Technologies, Inc. (K972403) ●
- IFS Cannulated Bone Screw Internal Fixation Systems, Inc. (K061620) .
- OsteoMed 1.2mm Auto-Drive Screw System OsteoMed Corp. (K023260) .
7. Device Description:
The GSO Bone Fixation Fasteners consist of sterile and non-sterile, single-use, smooth and threaded Kirschner wires and Steinmann pins (ranging in length from 4 to 12 inches and in diameter from 0.028 to 0.177 inches), and cortical, cancellous, and malleolar bone screws (ranging in length from 6 to 160 mm and in screw diameter from 1.5 to 6.5mm). All GSO Bone Fixation Fasteners are manufactured from 316-LVM stainless steel conforming to standard ASTM-F138.
8. Intended Use:
The GSO Bone Fixation Fasteners are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
** Warning: GSO Bone Fixation Devices are not indicated for spinal fixation. **
1
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- Summary of Technologies/Substantial Equivalence:
Every GSO Bone Fixation Fastener has the same intended use, similar design and the same indications for use as at least one of the following predicates: Sterile Kirschner Wires and Steinmann Pins – DePuy, Inc. (K960385), PLUS Cancellous Bone Screws - Plus Orthopedics (K011719), and BTI Cortical Bone Screws -Biodynamic Technologies, Inc. (K972403), OsteoMed 1.2mm Auto-Drive Screw System - OsteoMed Corporation (K023260). They are manufactured from the same material as the predicates: IFS Cannulated Bone Screw - Internal Fixation Systems, Inc. (K061620) and Sterile Kirschner Wires and Steinmann Pins -- DePuy, Inc. (K960385).
- Summary of Technologies/Substantial Equivalence:
10. Non-Clinical Testing:
Non-clinical testing was not necessary to determine substantial equivalence between the GSO Bone Fixation Fasteners and the predicates.
11. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the GSO Bone Fixation Fasteners and the predicates.
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Gold Standard Orthopaedics, L.L.C. % Mr. David Baughman President 1226 Rowan Street Louisville, KY 40203
JAN 3 1 2007
Re: K063589
Trade/Device Name: GSO Bone Fixation Fasteners Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 16, 2006 Received: December 1, 2006
Dear Mr. Baughman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. David Baughman
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0210 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Buehrum
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2. INDICATIONS FOR USE
510(k) Number (if known): N/A (unknown)
Device Name: GSO Bone Fixation Fasteners
Indications for Use:
The GSO Bone Fixation Fasteners are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
** Warning: GSO Bone Fixation Devices are not indicated for spinal fixation. **
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara buenn
Division of General. Restorative. and Neurological Devices
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510(k) Number K063589