(84 days)
Not Found
No
The summary describes a mechanical bone staple and its material properties and mechanical testing, with no mention of AI or ML.
No
The device is an orthopedic implant (bone staple) used for fixation of fractures, osteotomies, and joint arthrodesis, which is not typically classified as a therapeutic device in the sense of delivering therapy (e.g., drug, light, electrical stimulation), but rather as an assistive or structural device.
No
Explanation: The device is an implant for fracture and osteotomy fixation and joint arthrodesis. Its purpose is therapeutic (fixation and stabilization), not diagnostic.
No
The device description clearly states it is a bone staple implant made of titanium, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed 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 description clearly states that the ORBITUM X and VI Bone Staple is an implantable device used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot. This is a surgical device used within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or any other activities associated with in vitro diagnostics.
Therefore, the ORBITUM X and VI Bone Staple is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The ORBITUM X and VI Bone Staple is indicated for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
Orbitum X and VI implants are intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis Akin osteotomy, midfoot arthrodesis or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
Product codes
JDR
Device Description
Orbitum Bone Staple Implants, X and VI, have either radial or hourglass shaped superior profiles in three distinct sizes to coincide with the surgical approach. The legs of the device are configured to create compression upon implantation.
Orbitum Bone Staple Implants, are manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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:
Testing according to ASTM F564 was performed on the ORBITUM Bone Staple to establish equivalency to the predicate device. The tests included static compression bending, dynamic compression bending and axial pull-out testing.
ORBITUM Bone Staple Implants, are equivalent in mechanical function and properties to the predicate device, establishing equivalency in safety and effectiveness.
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.
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Image /page/0/Picture/0 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 acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font.
February 23, 2018
Orthovestments, LLC Robert Weinstein Managing Partner 1640 Powers Ferry Bldg 9 Marietta, Georgia 30067
Re: K173693
Trade/Device Name: Orbitum Bone Staple Implant, X and VI Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: November 13, 2017 Received: December 1, 2017
Dear Robert Weinstein:
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); medical device 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);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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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Indications for Use
510(k) Number (if known) K173693
Device Name
Orbitum Bone Staple Implant, X and VI
Indications for Use (Describe)
The ORBITUM X and VI Bone Staple is indicated for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
Orbitum X and VI implants are intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis Akin osteotomy, midfoot arthrodesis or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR |
| | 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 Orthovestments, LLC. The logo features a blue and white globe-like design with curved lines, suggesting a sense of global reach or interconnectedness. Below the graphic is the company name, "Orthovestments, LLC," written in a blue, sans-serif font. The overall design is clean and professional, conveying a sense of trust and reliability.
1630 Powers Ferry Road Bldg 23, Suite 100, Marietta, GA 30067 I p (404) 617-6939
510(k) Summary
As required by section 807.92(c)
December 1, 2017
Orthovestments, LLC is requesting marketing clearance for the Orbitum Bone Staple.
| A. Sponsor/Manufacturer: | Orthovestments, LLC
Dr. Robert Weinstein, Managing Partner |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Trade Name: | Orbitum Bone Staple Implant, X and VI |
| Common Name: | Fixation Staple |
| Classification Name: | Single/multiple component metallic bone fixation appliance and accessories (21 CFR 888.3030 Class II, Product Code JDR) |
| C. Predicate Device: | K043059 - Compression Staple and Simple Staple (Wright Medical Technologies);
K121277 – Z –staple (Z=medical Gmbh);
K161587 - Memodyn Staple (Telos Medical) |
D. Device Description:
Orbitum Bone Staple Implants, X and VI, have either radial or hourglass shaped superior profiles in three distinct sizes to coincide with the surgical approach. The legs of the device are configured to create compression upon implantation.
Orbitum Bone Staple Implants , are manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
- E. Intended Use:
The ORBITUM X and VI Bone Staple is indicated for fracture and osteotomy fixation and joint arthrodesis of the hand and foot
ORBITUM X and VI Implants are intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot arthrodesis or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
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F. Technological Characteristics:
The technological characteristics of the, ORBITUM X and VI Bone Staple are equivalent to the predicate device, except for the superior profile diameters and quantity / size of legs . -
G. Non-clinical Testing:
Testing according to ASTM F564 was performed on the ORBITUM Bone Staple to establish equivalency to the predicate device. The tests included static compression bending, dynamic compression bending and axial pull-out testing.
ORBITUM Bone Staple Implants, are equivalent in mechanical function and properties to the predicate device, establishing equivalency in safety and effectiveness.
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K173693 Page 2/2
Image /page/4/Picture/1 description: The image shows the logo for Orthovestments, LLC. The logo features a blue and white globe-like design with curved segments. Below the logo, the text "Orthovestments, LLC" is written in a blue, sans-serif font.
1630 Powers Ferry Road Bldg 23, Suite 100, Marietta, GA 30067 I p (404) 617-6939
- H. Conclusion:
The testing completed as well as a comparison of the technological characteristics has demonstrated that the ORBITUM X and VI Bone Staples, are substantially equivalent to the predicate device(s).