(181 days)
The Additive Orthopaedics Bunion System is indication and fusion of fractures, ostotomies and arthrodesis of small bones such as the foot and ankle.
The Additive Orthopaedics Bunion System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.
The Additive Orthopaedics Bunion System consists of a plate and screws (both locking and nonlocking) with surgical site preparation and insertion instruments. The devices is intended to be used for fixation following an osteotomy in bunion correction procedures. The plates are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The screws are manufactured from medical grade titanium alloy. (Ti-6AL-4V). The implants are provided sterile and intended for single use only. The bunion plate comes in 1 individual size and the screws come in 4 lengths.
The provided document is a 510(k) premarket notification for a medical device called the "Additive Orthopaedics Bunion System." This document does not describe a study involving an AI/Machine Learning device and human readers, nor does it provide acceptance criteria and performance metrics in the way requested for such studies.
This document describes a traditional medical device (metallic bone fixation appliances) and focuses on demonstrating substantial equivalence to pre-existing predicate devices through mechanical testing and comparison of technological characteristics.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, MRMC studies, or training sets, as these are not relevant to the content of this 510(k) submission.
Key takeaway from the document:
- Device: Additive Orthopaedics Bunion System (plate and screws for bone fixation).
- Purpose: To demonstrate substantial equivalence to legally marketed predicate devices for the indication of alignment, stabilization, and fusion of fractures, osteotomies, and arthrodesis of small bones (foot and ankle).
- Methods of demonstration: Comparison of technological characteristics (indications, dimensions, geometry, materials, manufacturing process) and mechanical testing (4-point bending per ASTM F382, static driving torque, removal torque, static axial pullout per F543).
- Conclusion: The device is substantially equivalent to the predicate devices and is expected to perform at least as well.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2017
Additive Orthopaedics, LLC Greg Kowalczyk President 83 Amelia Circle Little Silver, New Jersey 07739
Re: K163593
Trade/Device Name: Additive Orthopaedics Locking Lattice Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: May 25, 2017 Received: May 25, 2017
Dear Mr. Kowalczyk:
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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), 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.
Vincent J. Devlin -S
for
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) K163593
Device Name Additive Orthopaedics Bunion System
Indications for Use (Describe)
The Additive Orthopaedics Bunion System is indication and fusion of fractures, ostotomies and arthrodesis of small bones such as the foot and ankle.
| 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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510K Summary (Per 21 CFR 807.92)
| General Company Information: | Additive Orthopaedics, LLC.Gregory KowalczykPresident83 Amelia CircleLittle Silver, NJ 07739Phone: (732) 882-6633greg@additiveorthopaedics.com |
|---|---|
| Date Prepared: | February 9, 2017 |
General Device Information:
| Proprietary Name: | Additive Orthopaedics Bunion System |
|---|---|
| System Classification: | Common Name: Bunion System |
| Regulation Name: Single/multiple component metallicbone fixation appliances and accessories;Product Code: HRS- Class IIClassification Name and Reference: 21 CFR 888.3030 | |
| Regulation Name: Smooth or Threaded metallic bone fixation fastener and accessories;Product Code: HWC- Class IIClassification Name and Reference: 21 CFR 888.3040 |
Predicate Devices:
| Company | Product Name | 510K Number |
|---|---|---|
| Primary: Nextremity Solutions, Inc. | Restore Fixation System | K131061 |
| Additional: OrthoHelix Surgical Designs, Inc. | Mini MaxLock Extreme Plating System | K120157 |
| Additional: Osteomed | ExtremiLock System | K131445 |
| Additional: OrthoSolutions, Inc. | Ultos Foot Plating system | K141784 |
| Reference: Additive Orthopaedics, LLC | Hammertoe Correction System | K153207 |
| Reference: Additive Orthopaedics, LLC | Bone Wedge System | K160264 |
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Description
The Additive Orthopaedics Bunion System consists of a plate and screws (both locking and nonlocking) with surgical site preparation and insertion instruments. The devices is intended to be used for fixation following an osteotomy in bunion correction procedures. The plates are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The screws are manufactured from medical grade titanium alloy. (Ti-6AL-4V). The implants are provided sterile and intended for single use only. The bunion plate comes in 1 individual size and the screws come in 4 lengths.
Indications for Use
The Additive Orthopaedics Bunion System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.
(a) (6) Technological Characteristics Comparison
The Additive Orthopaedics Bunion System and the legally marketed predicated devices have similar indications, dimensions, geometry, materials and manufacturing process. The Additive Orthopaedics Bunion System is technologically substantially equivalent to the predicate devices.
(b) (1) Substantial Equivalence- Non-Clinical Evidence
Mechanical testing including 4 point bending (static and dynamic) per ASTM F382 for the predicate and subject device. Also included were static driving torque and removal torque, and static axial pullout per F543 for the subject device. In addition to the mechanical testing of the screws, an engineering analysis was performed for the subject device to show substantial equivalency with respect to insertion/removal torque, torsional strength, pull-out strength and bending strength. The results of these verification activities demonstrate that the Additive Orthopaedics Bunion System is substantially equivalent to the predicate device identified.
(b) (3) Substantial Equivalence - Conclusions
The Additive Orthopaedics Bunion System possesses the same technologic characteristics of the predicate devices. These characteristics include the intended use, basic design, material, manufacturing process, size and fundamental technology. The design characteristics of the subject system do not raise any different questions of safety and effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.
§ 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.