(27 days)
Not Found
No
The summary describes a system of bone plates, screws, and washers for fracture fixation, which are purely mechanical devices. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is described as an internal fixation system for bone fractures, fusions, or osteotomies, which falls under the category of surgical implants used to stabilize a treated condition rather than actively deliver a therapy.
No
The device is described as a system for internal fixation of bone fractures, fusions, or osteotomies, which is a therapeutic intervention, not a diagnostic one. It functions to stabilize bones rather than identify or characterize a condition.
No
The device description clearly states it is comprised of physical components (bone plates, screws, and washers) made of titanium alloy or stainless steel, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The provided text describes bone plates, screws, and washers. These are implants used for the internal fixation of bone fractures, fusions, or osteotomies. This is a surgical procedure performed inside the body.
- Intended Use: The intended use clearly states "internal fixation of bone fractures, fusions or osteotomies." This is a therapeutic and structural function, not a diagnostic one based on analyzing bodily specimens.
The device is a surgical implant, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
The OrthoNovis bones plates and screws system are intended to be used for internal fixation of bone fractures, fusions or osteotomies in the ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bone (such as humerus, ulna, radius, femur, tibia, and fibula, and small bones (such as metacarpals, metatarsals, phalanges). The washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments.
Product codes
HRS, HWC, HTN
Device Description
The bone fragment fixation plates and washers of various sizes, consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones, including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia,phalanges, carpals, metacarpals, tarsals, metatarsals and fibula. The washers are to function with screw head from breaking through the cortex of the bone by providing additional surface area during screw placement. The plates s are a one-piece device made of commercially pure titanium alloy or stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bone (such as humerus, ulna, radius, femur, tibia, and fibula), and small bones (such as metacarpals, metatarsals, phalanges). Also listed: acetabulum, carpals, tarsals.
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
Non-clinical and clinical characteristics are the provided primary and reference devices, including material, manufacturing method, design, chemical composition method and principle of operation. Engineering justifications were provided to demonstrate the subject devices have adequate mechanical properties.
Key Metrics
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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February 6, 2025
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
OrthoNovis, Inc. % Tawney Schwarz Regulatory Consultant Simple Path LLC 712 Lyndhurst St Unit 321 Dunedin, Florida 34698
Re: K250055
Trade/Device Name: BPS - Bone Fragment Fixation Plates, Screws and Washers 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, HTN Dated: January 10, 2025 Received: January 10, 2025
Dear Tawney Schwarz:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CHRISTOPHER FERREIRA -S
Christopher Ferreira, MS Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
BPS - Bone Fragment Fixation Plates, Screws and Washers
Indications for Use (Describe)
The OrthoNovis bones plates and screws system are intended to be used for internal fixation of bone fractures, fusions or osteotomies in the ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bone (such as humerus, ulna, radius, femur, tibia, and fibula, and small bones (such as metacarpals, metatarsals, phalanges). The washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) #:
510(k) Summary
Prepared on: 2025-01-06
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | OrthoNovis, Inc. |
|---|---|
| Applicant Address | 1 Hargrove Grade, Suite 2f Palm Coast FL 32137 United States |
| Applicant Contact Telephone | 352-807-3306 |
| Applicant Contact | Mr. Ken West |
| Applicant Contact Email | kwest@orthonovis.com |
| Correspondent Name | Simple Path LLC |
| Correspondent Address | 712 Lyndhurst St Unit 321 Dunedin FL 34698 United States |
| Correspondent Contact Telephone | 910-515-0918 |
| Correspondent Contact | Mrs. Tawney Schwarz |
| Correspondent Contact Email | tawney@simplepath.solutions |
21 CFR 807.92(a)(2)
| Device Trade Name | BPS - Bone Fragment Fixation Plates, Screws and Washers |
|---|---|
| Common Name | Single/multiple component metallic bone fixation appliances and accessories |
| Classification Name | Plate, Fixation, Bone |
| Regulation Number | 888.3030 |
| Product Code(s) | HRS, HWC, HTN |
21 CFR 807.92(a)(3)
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K130614 | BONE FRAGMENT AND FIXATION PLATES, SCREWS AND W | HRS |
| K110086 | IFS Bone Plates, Screws, and Washers | HRS |
| K113733 | Small and Large Fragments Osteosynthesis System NEOFIX | HRS |
21 CFR 807.92(a)(4)
Device Description Summary
The bone fragment fixation plates and washers of various sizes, consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones, including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia,phalanges, carpals, metacarpals, tarsals, metatarsals and fibula. The washers are to function with screw head from breaking through the cortex of the bone by providing additional surface area during screw placement. The plates s are a one-piece device made of commercially pure titanium alloy or stainless steel.
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Intended Use/Indications for Use
The OrthoNovis bones plates and screws system are internal fixation of bone fractures, fusions or osteotomies in the ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bone (such as humerus, ulna, and fibula, and small bones (such as metacarpals, metatarsals, phalanges). The washers are intended from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments.
Indications for Use Comparison
Indications for use are the same as the primary predicate (K130614).
Technological Comparison
Technological characteristics are the provided primary and reference devices, including material, design, chemical composition and principle of operation. The submission is to introduce additional material options (Ti6Al4V alloy and Commercially Pure Titanium), as well as to propose minor modifications to screw geometry.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical and clinical characteristics are the provided primary and reference devices, including material, manufacturing method, design, chemical composition method and principle of operation. Engineering justifications were provided to demonstrate the subject devices have adequate mechanical properties.
The BPS - Bone Fragment Fixation Plates, Screws and Washers are substantially equivalent to the primary predicate device (K130614).
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)