Locking Plates and Screws Systems

K240958 · Hebei Ruihe Medical Devices Co., Ltd. · HRS · Feb 10, 2025 · Orthopedic

Device Facts

• Record ID: K240958
• Device Name: Locking Plates and Screws Systems
• Applicant: Hebei Ruihe Medical Devices Co., Ltd.
• Product Code: HRS · Orthopedic
• Decision Date: Feb 10, 2025
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Locking Plates and Screws Systems is intended to provide fixation during fractures, fusions, and osteotomies. Locking Plates and Screws Systems is indicated for the clavicle, and small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.

Device Story

System comprises metal locking plates and screws for orthopedic fixation; plates available in ordinary and limited-contact types. Plates manufactured from pure titanium (ASTM F67); screws from titanium alloy (ASTM F136). Surface color anodized; supplied non-sterile. Used by surgeons in clinical settings for fracture stabilization, fusion, or osteotomy. Device provides mechanical support to bone fragments; surgeon selects appropriate plate/screw configuration based on anatomical site and fracture pattern. Benefits include rigid fixation to facilitate bone healing.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance testing included static four-point bending (ASTM F382), driving torque, torsional strength, and axial pullout (ASTM F543). Biocompatibility evaluated per ISO 10993. Sterilization validated per ISO 17665-1.

Technological Characteristics

Materials: Pure titanium (ASTM F67) for plates, titanium alloy (TC4, ASTM F136) for screws. Form factor: Various locking compression plates (clavicle, humerus, radius, ulna, femur, tibia, fibula, etc.) and screws (1.5-7.5 mm diameter). Energy source: None (mechanical). Sterilization: Non-sterile (end-user validated per ISO 17665-1).

Indications for Use

Indicated for patients requiring bone fixation for fractures, fusions, or osteotomies of the clavicle, small bones (metacarpals, wrist, metatarsals, tarsals, phalanges), and long bones (radius, ulna, humerus, olecranon, fibula, femur, tibia).

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

• BaiDe® Locking Plate System (K150009)
• DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS (K130108)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 10, 2025

Hebei Ruihe Medical Devices Co., Ltd. Mengjia Chi Regulatory Affairs Manager No. 599 Qinling St. High-tech Industrial Development Zone Shijiazhuang, Hebei 051430 China

Re: K240958

Trade/Device Name: Locking Plates and Screws Systems 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: April 7, 2024 Received: April 8, 2024

Dear Mengjia Chi:

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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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 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 mediation-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)

K240958

Device Name

Locking Plates and Screws Systems

Indications for Use (Describe)

Locking Plates and Screws Systems is intended to provide fixation during fractures, fusions, and osteotomies. Locking Plates and Screws Systems is indicated for the clavicle, and small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.

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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Image /page/4/Picture/0 description: The image contains a logo for Ruihe Medical. The logo consists of a circular emblem on the left and the text "瑞鹤医疗" and "RUIHE MEDICAL" on the right. The emblem features a stylized blue swirl with red accents. The Chinese characters "瑞鹤医疗" are written in blue, and the English text "RUIHE MEDICAL" is written in a smaller font size below the Chinese characters.

# K240958 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

#### 1. Date Prepared [21_CFR 807.92(a)(1)]

02/10/2025

#### 2. Submitter's Information [21 CFR 807.92(a)(1)]

| Company Name: | Hebei Ruihe Medical Devices, Ltd. |
|------------------|------------------------------------------------------------------------------------------------------|
| Company Address: | No. 599 Qinling Street, High-tech Industrial Development<br>Zone, Shijiazhuang, Hebei, 051430, China |
| Contact Person: | Ms. Meijia Chi |
| Phone: | 86 18712837922 |
| Email: | [e-mail] |

#### 3. Trade Name, Common Name, Classification [21 CFR 807,92(a)(2)]

Device Trade Name: Locking Plates and Screws Systems

Device Common Name: Plate, Fixation, Bone

Device Classification Name: Single/multiple component metallic bone fixation appliances and accessories Device Classification: Class II

Classification Review Panel: Orthopedic Panel

Classification Review Panel. Otr

By: /s/ C. L. URC

Product Code: HRS

Regulation Number: 21CFR 888.3030 (Primary)

Device Classification Name: Smooth or threaded metallic bone fixation fastener Common Name: Screw, Fixation, Bone Device Classification: Class II Classification Review Panel: Orthopedic Panel Product Code: HWC Regulation Number: 21CFR 888.3040

#### 4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)]

The identification of predicates within this submission is as follows: Predicate Devices #1 (Primary): 510 (k) Number: K150009 Product Name: BaiDe® Locking Plate System Submitter: Jiangsu BaiDe Medical Instrument Co. Ltd.

Predicate Devices #2: 510 (k) Number: K130108

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Product Name: DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS Submitter: Xiamen Double Engine Medical Material Co., Ltd.

#### 5. Description of the Device [21 CFR 807.92(a)(4)]

Locking Plates and Screws Systems consists of metal locking plates, metal locking screws and non-locking metal screws, of which the metal locking plates offered are divided into ordinary type and limited-contact type. The locking plates are made of pure titanium material (TA3G per ASTM F67), and the metal bone screws are made of titanium-alloy (TC4 per ASTM F136). The product surface is color anodized, and the delivery state of the product is non-sterile.

#### 6. Indications for Use [21 CFR 807.92(a)(5)]

Locking Plates and Screws Systems is intended to provide fixation during fractures, fusions, and osteotomies. Locking Plates and Screws is indicated for the clavicle, and small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.

#### 7. Technological Characteristic [21 CFR 807.92(a)(6)]

The Locking Plates and Screws Systems consists of metal locking plates including but not limited to: clavicle locking compression plates (67-147 mm length), proximal humerus locking compression plates (43-290 mm length), distal humerus compression plates (58-302mm length), proximal ulnar locking compression plate(50-216 mm), proximal radius locking compression plates (32-55.5 mm length), distal radius locking compression plates (40-240 mm length), proximal femoral locking compression plates (43-332 mm length), distal femoral locking compression plates (121-395 mm length), proximal tibial locking compression plates (69-400 mm length), distal tibial locking compression plates (64-288 mm length), distal fibula locking compression plates (62-233 mm length), locking compression plate (46-482 mm length), epiphyseal locking plates (28-411 mm length), achilles locking plates (41-76 mm length), navicular locking plates (58 mm length), straight locking compression plates (16.5-102 mm lengths), metatarsophalangeal locking plates (39-57 mm lengths), small L-shaped locking compression locking plates (32-71.8 mm length), small T-shaped locking compression plates (29.5-105.5 mm length), condylar locking compression plates (12-90 mm lengths), wrist fusion locking compression plates (117 mm length), as well as locking and non-locking screws (1.5-7.5 mm diameter, and 2-150 mm length).

| Clinical Testing | Not Applicable |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical<br>Testing | Mechanical Performance Testing was conducted according to ASTM F543<br>and ASTM F382. Driving torque, torsional strength, and axial pullout<br>testing were conducted on the subject and predicate device screws<br>according to ASTM F543. Four-point bend testing was conducted on the<br>subject and predicate device plates according to ASTM F382.<br>Sterilization Validation testing was conducted according to International<br>Organization for Standardization (ISO) 17665-1: Sterilization of health<br>care products – Moist heat – Part 1: Requirements for the development,<br>validation, and routine control of a sterilization process for medical |

#### 8. Clinical Testing and Non-Clinical Testing

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| | devices. |
|--|--------------------------------------------------------------------------------|
| | Biocompatibility Testing was conducted according to ISO 10993 as well as |
| | the recommendations outlined in FDA guidance document, "Use of |
| | International Standard ISO 10993-1, Biological evaluation of medical devices – |
| | Part 1: Evaluation and testing within a risk management process." |
| | |

## 9. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

- 9.1 Comparison between the subject device and the Safety and Performance Based Pathway

| Table 1 | Subject Device<br>Locking Plates and<br>Screws Systems | Orthopedic Fracture Fixation Plates<br>– Performance Criteria for Safety and<br>Performance Based Pathway and<br>Orthopedic Non-Spinal Metallic Bone<br>Screws and Washers - Performance<br>Criteria for Safety and Performance<br>Based Pathway | SE<br>Discussion |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Product Code | HRS | HRS | Same |
| Regulation No. | 21 CFR 888.3030 | 21 CFR 888.3030 | Same |
| Intended Use | Locking Plates and<br>Screws Systems is<br>intended to provide<br>fixation during<br>fractures, fusions, and<br>osteotomies. Locking<br>Plates and Screws<br>Systems is indicated<br>for the clavicle, and<br>small bones including<br>the metacarpals, wrist,<br>metatarsals, tarsals and<br>phalanges, and long<br>bones including the<br>radius, ulna, humerus,<br>olecranon, fibula,<br>femur, and tibia. | The fracture fixation plates that fall<br>within the scope of this guidance<br>document are intended for<br>osteosynthesis (i.e., rigid fixation of<br>opposing bone fragments for fracture<br>fixation, osteotomy, or arthrodesis). | Note No.1,<br>Note No.4 |
| Material | | | |
| | TA3G conforms to<br>ASTM F67 and TC4<br>conforms to ASTM<br>F136 | • ASTM F136 Standard<br>Specification for Wrought<br>Titanium-6 Aluminum-4 Vanadium<br>ELI (Extra Low Interstitial) Alloy<br>for Surgical Implant Applications<br>(UNS R56401)<br>• ASTM F1472 Standard<br>Specification for Wrought Titanium<br>-6Aluminum -4Vanadium Alloy for<br>Surgical Implant Applications<br>(UNS R56400)<br>• ASTM F1295 Standard<br>Specification for Wrought Titanium-<br>6 Aluminum-7Niobium Alloy for<br>Surgical<br>Implant Applications (UNS R56700)<br>• ASTM F67 Standard Specification<br>for Unalloyed Titanium, for Surgical<br>Implant Applications (UNS R50250,<br>UNS R50400, UNS R50550, UNS<br>R50700)<br>• ASTM F138 Standard<br>Specification for Wrought 18<br>Chromium-14 Nickel-2.5<br>Molybdenum Stainless Steel Bar<br>and Wire for Surgical Implants<br>(UNS S31673)<br>• ASTM F139 Standard<br>Specification for Wrought 18<br>Chromium-14 Nickel-2.5<br>Molybdenum Stainless Steel Sheet<br>and Strip for Surgical Implants<br>(UNS S31673)<br>ASTM F1537 Standard Specification<br>for Wrought Cobalt-28-Chromium-6-<br>Molybdenum Alloys for Surgical<br>Implants (UNS R31537, UNS R31538,<br>and UNS R31539) | Note No.2,<br>Note No.5 |
| Mechanical<br>Performance | Test name: Static Four-<br>Point Bending<br>Methodology: FDA-<br>recognized version of<br>ASTM F382 Standard<br>Specification and<br>Test Method for<br>Metallic Bone Plates.<br><br>Test name: Driving | Test name: Static Four-Point Bending<br>Methodology: FDA-recognized<br>version of ASTM F382 Standard<br>Specification and Test Method for<br>Metallic Bone Plates. | Note No.6 |
| | torque, Torsional<br>strength, Axial pullout<br>testing<br>Methodology: FDA-<br>recognized version of<br>ASTM F543 Standard<br>Specification and Test<br>Methods for Metallic<br>Medical Bone Screws | | |
| Sterilization<br>(devices labeled<br>as sterile) and<br>Reprocessing<br>(end-user<br>sterilized)<br>Validation | Test name:<br>Sterilization (devices<br>labeled as sterile) and<br>Reprocessing (end-<br>user sterilized)<br>Methodology:<br>International<br>Organization for<br>Standardization (ISO)<br>17665-1 Sterilization<br>of health care products<br>- Moist heat - Part<br>1: Requirements for<br>the development,<br>validation, and<br>routine control of a<br>sterilization process for<br>medical devices | Test name: Sterilization (devices<br>labeled as sterile) and Reprocessing<br>(end-user sterilized)<br>Methodology: FDA currently-<br>recognized versions of the following<br>consensus standards (as applicable):<br>International Organization for<br>Standardization (ISO) 17665-1<br>Sterilization of health care products<br>- Moist heat - Part 1:<br>Requirements for the development,<br>validation, and routine control of<br>a sterilization process for medical<br>devices<br>• ISO 11135-1 Sterilization of health<br>care products - Ethylene oxide – Part 1:<br>Requirements for development,<br>validation, and routine control of a<br>sterilization process for medical devices<br>• ISO 11137-1 Sterilization of health<br>care products - Radiation - Part 1:<br>Requirements for development,<br>validation, and routine control of a | Note No.7 |
| | | sterilization process for medical devices<br>Contains Nonbinding<br>Recommendations:<br>• ISO 11607-1 Packaging for terminally<br>sterilized medical devices – Part 1:<br>Requirements for materials, sterile<br>barrier systems and packaging systems<br>• ISO 11607-2 Packaging for terminally<br>sterilized medical devices – Part 2:<br>Validation requirements for<br>forming, sealing and assembly processes | |
| Biocompatibility<br>Evaluation | Test name:<br>Cytotoxicity test<br>Methodology: Use of<br>International Standard<br>ISO 10993-1,<br>Biological evaluation<br>of medical devices –<br>Part 1: Evaluation and<br>testing within a risk<br>management process | Test name: Biocompatibility<br>endpoints Methodology: Use of<br>International Standard ISO 10993-<br>1, Biological evaluation of medical<br>devices – Part 1: Evaluation and<br>testing within a risk management<br>process | Same |

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# 9.2 Comparison of test standards for the subject device and the Predicate Device

| Table 2 | Subject Device | Predicate Device 1 | SE Discussion |
|-------------|--------------------------------------|-----------------------------|-----------------|
| Device Name | Locking Plates and Screws<br>Systems | BaiDe® Locking Plate System | N/A |
| ASTM F382 | Yes | Yes | Same, Note No.6 |
| ASTM F543 | Yes | Yes | Same, Note No.6 |

| Table 3 | Subject Device | Predicate Device 2 | SE Discussion |
|-------------|--------------------------------------|--------------------------------------------------|-----------------|
| Device Name | Locking Plates and Screws<br>Systems | DOUBLE ENGINE BONE<br>PLATE AND SCREW<br>SYSTEMS | N/A |
| ASTM F382 | Yes | Yes | Same, Note No.6 |
| ASTM F543 | Yes | Yes | Same, Note No.6 |

## 9.3 Justification

| Note ID | Justification |
|-----------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Note No.1 | Subject Device lists its indications in detail, with consistent basic uses and<br>can be regarded as substantially equivalent. |
| Note No.2 | The materials used in the plates are within the range of the SPBP path list<br>material and are therefore considered substantially equivalent. |
| Note No.3 | The plate is within the SPBP path enumeration range and therefore considered |

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| | substantially equivalent. |
|-----------|-----------------------------------------------------------------------------------|
| Note No.4 | Subject Device lists its indications in detail, which is consistent with the |
| | intended uses outlined in the SPBP guidance document and predicate devices, |
| | and therefore can be regarded as substantially equivalent. |
| Note No.5 | The materials used for the bone screws are within the SPBP path |
| | enumerated material range and are therefore considered substantially |
| | equivalent. |
| Note No.6 | Using the internationally recognized standard ASTM F543 and ASTM F832, |
| | test results meet the SPBP path requirements or are similar to the results of the |
| | predicate device, therefore demonstrating that the subject device mechanical |
| | performance results are as safe and effective as the predicate devices. |
| Note No.7 | The source criteria for the recommended sterilization parameters for the |
| | subject device are within the SPBP path listing criteria and are therefore |
| | considered substantially equivalent. |

#### 10. Conclusion_[21_CFR 807.92(b)(3)1

The subject device has same intended use, similar performance, equivalent testing standards, and all technological characteristics are similar to the predicate device or Safety and Performance Based Pathway Criteria, indicate that the proposed device is as safe and effective as the predicate device.

Any differences between the proposed subject device and the predicate device or Safety and Performance Based Pathway Criteria do not affect the intended use, technological characteristics, safety and/or effectiveness. Therefore, the subject device is as safe and effective as the predicate device identified.