(58 days)
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No
The summary describes a system of bone plates and screws for fracture fixation, with performance testing focused on mechanical properties. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes.
The device is indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults. This involves treating an ailment, making it a therapeutic device.
No
Explanation: The device, the BPS Wrist Fracture System, is described as being "indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults." This indicates it is a therapeutic device used for treatment (fixation), not a diagnostic device used for identifying illnesses or conditions. The performance studies also focus on the mechanical strength of the implants, further supporting its role as a therapeutic device.
No
The device description explicitly states that the system includes bone plate and bone screw implants, which are physical hardware components made of titanium. The performance studies also focus on the mechanical properties of these physical implants.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The BPS Wrist Fracture System is described as a system of bone plates and bone screws designed for the fixation of fractures and osteotomies in the distal radius. These are implanted devices used directly on the bone during surgery.
- Intended Use: The intended use is for the fixation of fractures and osteotomies, which is a surgical procedure, not a diagnostic test performed on a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is clearly an orthopedic surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BPS Wrist Fracture System is indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults. The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.
Product codes
HRS, HWC
Device Description
The BPS Wrist Fracture System includes bone plate and bone screw implants designed for fixation of certain fractures, fusions, or osteotomies in the distal radius. To meet various patient anatomical needs, the BPS Wrist Fracture System features several sizes of distal radius plates as well as various styles and sizes of locking, nonlocking, and cortical bone screws. The plates are manufactured from Commercially Pure Titanium Grade 4 per ASTM F67. The screws are manufactured from Titanium Alloy Grade 5 (Ti-6AI-4V ELI) per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
Indicated Patient Age Range
adults
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
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Summary of Performance Studies
The BPS Wrist Fracture System has been tested in the following test modes:
- Static Four-Point Bending, conducted per ASTM F382, of the worst-case subject plates met the performance criteria as outlined in the FDA Guidance 'Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway'.
- Torsional yield strength, conducted per ASTM F543, of the worst-case subject screws met the performance criteria as outlined in the FDA Guidance 'Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway'.
- Driving torque of the worst-case subject screws was conducted per ASTM F543 and met the performance criteria as outlined in the FDA Guidance 'Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway'.
- Axial Pullout Strength of the worst-case subject screws was evaluated using an engineering analysis, which met the performance criteria as outlined in the FDA Guidance 'Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway'.
The results of this non-clinical testing show that the strength of the BPS Wrist Fracture System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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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October 4, 2024
OrthoNovis, Inc. % Hannah Taggart Regulatory Associate Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K242343
Trade/Device Name: BPS Wrist Fracture System 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: August 7, 2024 Received: August 7, 2024
Dear Hannah Taggart:
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, Biomedical Engineer 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
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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 Wrist Fracture System
Indications for Use (Describe)
The BPS Wrist Fracture System is indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults. The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.
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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K242343 510(k) Summary
| Submitter's Name: | OrthoNovis, Inc. |
|---|---|
| Submitter's Address: | 1 Hargrove Grade, 2F |
| Palm Coast, Florida 32137 | |
| Submitter's Telephone: | 833-950-0127 |
| Contact Person: | Hannah Taggart, MS |
| Empirical Technologies | |
| 719-457-1152 | |
| htaggart@empiricaltech.com | |
| Date Summary was Prepared: | October 2, 2024 |
| Trade or Proprietary Name: | BPS Wrist Fracture System |
| Device Classification Name: | Plate, Fixation, Bone |
| Classification & Regulation #: | Class II per 21 CFR §888.3030 and 21 CFR §888.3040 |
| Product Code: | HRS |
| Additional Product Code: | HWC |
| Classification Panel: | Orthopedic - Restorative, Repair and Trauma Devices (DHT6C) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The BPS Wrist Fracture System includes bone plate and bone screw implants designed for fixation of certain fractures, fusions, or osteotomies in the distal radius. To meet various patient anatomical needs, the BPS Wrist Fracture System features several sizes of distal radius plates as well as various styles and sizes of locking, nonlocking, and cortical bone screws. The plates are manufactured from Commercially Pure Titanium Grade 4 per ASTM F67. The screws are manufactured from Titanium Alloy Grade 5 (Ti-6AI-4V ELI) per ASTM F136.
INDICATIONS FOR USE
The BPS Wrist Fracture System is indicated for the fixation of simple and complex intra- articular and extraarticular fractures, and for osteotomies of the distal radius in adults.
The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. The predicates included in this submission were selected based on the best practices described in the FDA Draft Guidance document Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. Predicate clearance information and labeling documentation is shown in Appendix B. Specifically, the following characteristics are the same between the subject and predicates:
- Indications for Use
- Anatomical Site for Use
- . Materials of manufacture
- . Plate Sizes
- Screw Styles and Sizes ●
Minor differences in design do not raise questions for the safety and efficacy of the subject device since the performance testing of the subject device established the substantial equivalence despite those differences.
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Predicate Devices
| 510k # | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate Type |
|---|---|---|---|---|
| K191641 | AFFINITY Variable Angle Distal Radius System | Industrias Medicas Sampedro S.A.S | HRS, HWC | Primary |
| K233919 | VariAx 2 Distal Radius System | Stryker GmbH | HWC | Additional |
| K083694 | 2.4mm VA-LCP Volar Distal Radius System | Synthes (USA) | HRS | Additional |
PERFORMANCE DATA
The BPS Wrist Fracture System has been tested in the following test modes:
- Static Four-Point Bending, conducted per ASTM F382, of the worst-case subject plates met the . performance criteria as outlined in the FDA Guidance 'Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway'.
- Torsional yield strength, conducted per ASTM F543, of the worst-case subject screws met the performance criteria as outlined in the FDA Guidance 'Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathwav'.
- . Driving torque of the worst-case subject screws was conducted per ASTM F543 and met the performance criteria as outlined in the FDA Guidance 'Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway'.
- . Axial Pullout Strength of the worst-case subject screws was evaluated using an engineering analysis, which met the performance criteria as outlined in the FDA Guidance 'Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway'.
The results of this non-clinical testing show that the strength of the BPS Wrist Fracture System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the BPS Wrist Fracture System is substantially equivalent to the predicate device.