(25 days)
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.
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 Fractures several sizes of distal radius plates as well as various styles of locking, non-locking, 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-6Al-4V ELI) per ASTM F136.
I'm sorry, but based on the provided FDA 510(k) clearance letter for the "BPS Wrist Fracture System," this device is a physical medical implant (a metallic bone fixation appliance) and not an AI or software-based medical device.
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/software performance metrics (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, etc.) is not present in this document.
The 510(k) summary explicitly states:
- "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."
- "The plates are manufactured from Commercially Pure Titanium Grade 4 per ASTM F67. The screws are manufactured from Titanium Alloy Grade 5 (Ti-6Al-4V ELI) per ASTM F136."
- The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section only mentions "cleaning, sterilization, biocompatibility, mechanical and performance characteristics," which are typical for physical implants, not AI/software.
None of the provided text suggests any AI or software component requiring the kind of study details you've asked for.
To answer your specific questions related to AI/software, I would need a 510(k) clearance letter or similar documentation for an AI/software medical device.
FDA 510(k) Clearance Letter - BPS Wrist Fracture System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
March 17, 2025
OrthoNovis, Inc.
℅ Tawney Schwarz
Regulatory Consultant
Simple Path LLC
712 Lyndhurst St
Unit 321
Dunedin, Florida 34698
Re: K250498
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: February 20, 2025
Received: February 20, 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.
Page 2
K250498 - Tawney Schwarz Page 2
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250498 - Tawney Schwarz Page 3
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, M.S.
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K250498
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary
510(k)#: K250498 Prepared on: 2025-03-04
Contact Details
21 CFR 807.92(a)(1)
| Field | Value |
|---|---|
| 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 |
Device Name
21 CFR 807.92(a)(2)
| Field | Value |
|---|---|
| Device Trade Name | BPS Wrist Fracture System |
| Common Name | Plate, Fixation, Bone |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories |
| Regulation Number | 888.3030 |
| Product Code(s) | HRS, HWC |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K242343 | BPS Wrist Fracture System | HRS |
| K191641 | AFFINITY Variable Angle Distal Radius System | HRS |
Device Description Summary
21 CFR 807.92(a)(4)
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 patient anatomical needs, the BPS Wrist Fracture System features several sizes of distal radius plates as well as various styles and sizes of locking, non-locking, 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-6Al-4V ELI) per ASTM F136.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
Page 6
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.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The subject has the same indications for use as the predicate.
Technological Comparison
21 CFR 807.92(a)(6)
The subject and predicate devices have the same technological characteristics, including indications for use, principle of operation, design and materials. In comparison to the K242343 predicate, the subject device has wider proximal portion at the carpal side of the plates. 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. 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
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
The subject devices are substantially equivalent in non-clinical performance testing to the predicate devices, including cleaning, sterilization, biocompatibility, mechanical and performance characteristics.
§ 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.