BPS Wrist Fracture System

K250498 · Orthonovis, Inc. · HRS · Mar 17, 2025 · Orthopedic

Device Facts

• Record ID: K250498
• Device Name: BPS Wrist Fracture System
• Applicant: Orthonovis, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 17, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

BPS Wrist Fracture System consists of metallic bone plates and screws for internal fixation of distal radius fractures and osteotomies. Plates are applied to bone to stabilize fractures; screws (locking, non-locking, cortical) secure plates to bone. Used in clinical/surgical settings by orthopedic surgeons. Provides mechanical stabilization to facilitate bone healing. System includes various plate sizes and screw styles to accommodate patient anatomy.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by non-clinical performance testing including mechanical, biocompatibility, cleaning, and sterilization evaluations.

Technological Characteristics

Plates: Commercially Pure Titanium Grade 4 (ASTM F67). Screws: Titanium Alloy Grade 5 (Ti-6Al-4V ELI) (ASTM F136). Mechanical fixation system. Dimensions vary by plate size. Non-sterile/sterilizable.

Indications for Use

Indicated for fixation of simple and complex intra-articular and extra-articular fractures and osteotomies of the distal radius in adults (AO types A2, A3, B1, B3, C1, C2, C3).

Regulatory Classification

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.

Predicate Devices

• BPS Wrist Fracture System (K242343)
• AFFINITY Variable Angle Distal Radius System (K191641)

Submission Summary (Full Text)

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March 17, 2025

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it.

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.

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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 ([e-mail]) or phone [phone] 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

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### Indications for Use

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)

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K250498 510(k) #:

## 510(k) Summary

Prepared on: 2025-03-04

### 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 | [e-mail] | |
| 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 | [e-mail] | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | BPS Wrist Fracture System | |
| Common Name | Plate, Fixation, Bone | |
| Classification Name | Single/multiple component metallic bone fixation appliances and<br>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 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.

Intended Use/Indications for Use

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The BPS Wrist Fracture System is indication 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

The subject has the same indications for use as the predicate.

## Technological Comparison

The subject and predicate devices have 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 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.

### 21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)