Orbitum Bone Staple Implant, X and VI

K173693 · Orthovestments, LLC · JDR · Feb 23, 2018 · Orthopedic

Device Facts

• Record ID: K173693
• Device Name: Orbitum Bone Staple Implant, X and VI
• Applicant: Orthovestments, LLC
• Product Code: JDR · Orthopedic
• Decision Date: Feb 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Metallic bone fixation staple; radial or hourglass-shaped superior profiles; designed for fracture/osteotomy fixation and joint arthrodesis in hand and foot. Legs configured to provide compression upon implantation. Used by surgeons in clinical settings for orthopedic procedures. Provides mechanical stabilization of bone segments to facilitate healing/fusion. Benefits patient through secure fixation of osteotomies and arthrodesis sites.

Clinical Evidence

Bench testing only. Testing performed per ASTM F564 included static compression bending, dynamic compression bending, and axial pull-out testing to demonstrate mechanical equivalence to predicate devices.

Technological Characteristics

Material: Grade 23 Titanium (Ti-6Al-4V ELI) per ASTM F136. Form factor: Radial or hourglass-shaped superior profiles in three sizes. Function: Compression bone fixation. Mechanical testing: ASTM F564.

Indications for Use

Indicated for fracture and osteotomy fixation and joint arthrodesis of the hand and foot, including LisFranc arthrodesis, forefoot mono/bi-cortical osteotomies, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot arthrodesis/osteotomies, hallux valgus treatment (Scarf and Chevron), and metatarsocuneiform joint arthrodesis for metatarsus primus varus.

Regulatory Classification

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.

Predicate Devices

• Compression Staple and Simple Staple (K043059)
• Z-staple (K121277)
• Memodyn Staple (K161587)

Submission Summary (Full Text)

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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);

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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 ([e-mail]) or phone [phone] 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) | |
|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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 [phone]

## 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<br>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);<br>K121277 – Z –staple (Z=medical Gmbh);<br>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.

- 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 [phone]

- 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).