(71 days)
No
The summary describes a patient-specific 3D printed orthopedic plate based on CT scans, but there is no mention of AI or ML being used in the design, manufacturing, or application of the device. The patient-specific nature is achieved through the use of a previously cleared CT scanning protocol and 3D printing, not through AI/ML algorithms.
Yes.
The device is used for alignment, stabilization, and fusion of fractures, osteotomies, and arthrodesis, which are therapeutic interventions.
No
Explanation: The device is described as a surgical implant (plate) used for alignment, stabilization, and fusion of bones. It does not perform any diagnostic function.
No
The device description clearly states it is a physical implant (plate) made of titanium alloy, not software.
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.
- Device Description: The provided text describes a surgical implant (a plate) used to stabilize and fuse bones in the foot and ankle. It is a physical device implanted into the body during surgery.
- Intended Use: The intended use is for "alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones." This is a surgical procedure, not a diagnostic test performed on a sample.
- Input: The input is a CT scan, which is used for planning and manufacturing the patient-specific device, not for analyzing a biological sample.
The device is a surgical implant and falls under the category of orthopedic devices.
N/A
Intended Use / Indications for Use
The Additive Orthopaedics Patient Specific 3D Printed Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. It is a patient specific device.
Product codes
HRS, HWC
Device Description
The Additive Orthopaedics Patient Specific 3D Printed Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. This is a patient specific device which utilizes the CT scanning protocol previously cleared in K180239 by Additive Orthopaedics. These patient specific devices are manufactured within a size range of 30-80mm and are supplied non-sterile.
The subject device is manufactured from medical grade titanium alloy Ti6Al4V ELI and allows the surgeon to align and stabilize small bone osteotomies such as MPJ fusions, calcaneal osteotomies, Evans Osteotomies, opening wedge osteotomies and others. The plate is fixated using both locking and non-locking screws which were cleared in K 163593 (Additive Orthopaedics) and compatible with Additive Orthopaedics wedges (K153207 and K180239).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanning protocol
Anatomical Site
Small bones such as the foot and ankle.
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)
Mechanical testing including 4-point bending (static and dynamic) per ASTM F382 as well as static torsion, static driving torque and removal torque, and static axial pullout per F543 were conducted on the predicate device and may be referenced in K170214.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
January 10, 2019
Image /page/0/Picture/1 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Additive Orthopaedics Gregory Kowalczyk President 44 Riverdale Ave Monmouth Beach, New Jersey 07750
Re: K183011
Trade/Device Name: Additive Orthopaedics Patient Specific 3D Locking Lattice Plates 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: October 30, 2018 Received: October 31, 2018
Dear Gregory 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm_identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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,
Shumaya Ali -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183011
Device Name
Additive Orthopaedics Patient Specific 3D Lattice Locking Plates
Indications for Use (Describe)
The Additive Orthopaedics Patient Specific 3D Printed Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. It is a patient specific device.
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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3
Additive Orthopaedics, LLC Patient Specific 3D Locking Lattice Plates
December 28, 2018
| 510K Summary (Per 21
| CFR 807.92) | ||
|---|---|---|
| General Company Information: | ||
| 44 Riverdale Ave | Additive Orthopaedics, LLC. | |
| Gregory Kowalczyk | ||
| President | ||
| Monmouth Beach, NJ 07750 | ||
| Phone: (732) 882-6633 | ||
| greg@additiveorthopaedics.com | ||
| Date Prepared: | December 28, 2018 | |
| General Device Information: | ||
| Proprietary Name: | Additive Orthopaedics Patient Specific 3D Printed | |
| Locking Lattice Plates | ||
| System Classification: | Common Name: Plate, Fixation, Bone | |
| Regulation Name: Single/multiple component metallic bone | ||
| fixation appliances and accessories; | ||
| Product Code: HRS--- Class II | ||
| Classification Name and Reference: 21 CFR 888.3030 | ||
| Regulation Name: Smooth or Threaded metallic bone fixation | ||
| fastener and accessories; | ||
| Product Code: HWC--- Class II | ||
| Predicate Devices: | ||
| Primary Predicate Device: | ||
| Company | ||
| Additive Orthopaedics | Product Name | |
| Locking Lattice Plates | 510K Number | |
| K170214 | ||
| Additional Predicate Device: | ||
| Company | ||
| BIOPRO, INC. | Product Name | |
| BioPro Foot Plating System | 510K Number | |
| K162674 | ||
| Reference Device: | ||
| Company | ||
| Additive Orthopaedics | Product Name | |
| Patient Specific 3D Printed Bone Segments | 510K Number | |
| K180239 |
The predicate devices have not been the subject of any design related recall.
4
Additive Orthopaedics, LLC Patient Specific 3D Locking Lattice Plates
December 28, 2018
Device Description
The Additive Orthopaedics Patient Specific 3D Printed Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. This is a patient specific device which utilizes the CT scanning protocol previously cleared in K180239 by Additive Orthopaedics. These patient specific devices are manufactured within a size range of 30-80mm and are supplied non-sterile.
The subject device is manufactured from medical grade titanium alloy Ti6Al4V ELI and allows the surgeon to align and stabilize small bone osteotomies such as MPJ fusions, calcaneal osteotomies, Evans Osteotomies, opening wedge osteotomies and others. The plate is fixated using both locking and non-locking screws which were cleared in K 163593 (Additive Orthopaedics) and compatible with Additive Orthopaedics wedges (K153207 and K180239).
Indications for Use
The Additive Orthopaedics Patient Specific 3D Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. This is a patient specific device.
Comparison of Technological Characteristics with the Predicate Device
Technological Characteristics Comparison
The Additive Orthopaedics Patient Specific 3D Locking Lattice Plate and the legally marketed predicate devices have similar indications, geometry, materials and manufacturing process. The subject device uses similar technology as the predicate to manufacture the plates. The difference is that the subject device is patient specific and the dimensions and geometry shall fall within the size ranges of 30-80mm. The dimensions and geometry of the Patient Specific 3D Printed Locking Lattice plates are patient specific, utilizing a previously cleared CT scanning protocol (K180239).
Substantial Equivalence Non-Clinical Evidence
The device is manufactured using similar materials and manufacturing methods to the predicate device. The only difference is that the plates are manufactured for a specific patient using previously cleared CT scan protocols. Mechanical testing including 4-point bending (static and dynamic) per ASTM F382 as well as static torsion, static driving torque and removal torque, and static axial pullout per F543 were conducted on the predicate device and may be referenced in K170214.
Substantial Equivalence --- Conclusions
The Additive Orthopaedics Patient Specific 3D Locking Lattice Plates have similar technologic characteristics of the predicate devices. These characteristics include the basic design, material, manufacturing process, size and fundamental technology. The differences between the subjected device and the predicate are the intended use. Specifically, the subject device is a patient specific device. The design characteristics of the subject system raises no new safety and effectiveness questions. From the evidence submitted in this 510(k), the subject devices can be expected to perform the same as the predicate device.