(308 days)
Not Found
No
The summary describes a mechanical fixation system made of metal plates and screws, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device, "Locking Plates and Screws Systems," is intended to provide fixation for fractures, fusions, and osteotomies, which is a supportive and reconstructive function rather than directly providing therapy.
No
The device description indicates that "Locking Plates and Screws Systems" are used to provide fixation during fractures, fusions, and osteotomies, and are composed of metal plates and screws. This describes a therapeutic device used for treatment, not a diagnostic device which identifies or characterizes a disease or condition.
No
The device description explicitly states it consists of metal locking plates and screws, which are hardware components, not software.
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, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The description clearly states that this device is a system of metal plates and screws intended for fixation during fractures, fusions, and osteotomies. This is a surgical implant used within the body to stabilize bones.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or any other activity typically associated with IVD devices.
Therefore, based on the provided information, the Locking Plates and Screws Systems is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
HRS, HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
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
Mechanical Performance Testing was conducted according to ASTM F543 and ASTM F382. Driving torque, torsional strength, and axial pullout testing were conducted on the subject and predicate device screws according to ASTM F543. Four-point bend testing was conducted on the subject and predicate device plates according to ASTM F382. Sterilization Validation testing was conducted according to International Organization for Standardization (ISO) 17665-1: Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical 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."
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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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.
1
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
2
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
3
Indications for Use
Submission Number (if known)
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 |
| Zone, Shijiazhuang, Hebei, 051430, China | |
| Contact Person: | Ms. Meijia Chi |
| Phone: | 86 18712837922 |
| Email: | chimengjia@ruihe-med.com |
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
5
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 | |
| Testing | Mechanical Performance Testing was conducted according to ASTM F543 |
| and ASTM F382. Driving torque, torsional strength, and axial pullout | |
| testing were conducted on the subject and predicate device screws | |
| according to ASTM F543. Four-point bend testing was conducted on the | |
| subject and predicate device plates according to ASTM F382. | |
| Sterilization Validation testing was conducted according to International | |
| Organization for Standardization (ISO) 17665-1: Sterilization of health | |
| care products – Moist heat – Part 1: Requirements for the development, | |
| validation, and routine control of a sterilization process for medical |
8. Clinical Testing and Non-Clinical Testing
6
| 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
Locking Plates and
Screws Systems | Orthopedic Fracture Fixation Plates
– Performance Criteria for Safety and
Performance Based Pathway and
Orthopedic Non-Spinal Metallic Bone
Screws and Washers - Performance
Criteria for Safety and Performance
Based Pathway | SE
Discussion |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Product Code | HRS | HRS | Same |
| Regulation No. | 21 CFR 888.3030 | 21 CFR 888.3030 | Same |
| 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. | The fracture fixation plates that fall
within the scope of this guidance
document are intended for
osteosynthesis (i.e., rigid fixation of
opposing bone fragments for fracture
fixation, osteotomy, or arthrodesis). | Note No.1,
Note No.4 |
| Material | | | |
| | TA3G conforms to
ASTM F67 and TC4
conforms to ASTM
F136 | • ASTM F136 Standard
Specification for Wrought
Titanium-6 Aluminum-4 Vanadium
ELI (Extra Low Interstitial) Alloy
for Surgical Implant Applications
(UNS R56401)
• ASTM F1472 Standard
Specification for Wrought Titanium
-6Aluminum -4Vanadium Alloy for
Surgical Implant Applications
(UNS R56400)
• ASTM F1295 Standard
Specification for Wrought Titanium-
6 Aluminum-7Niobium Alloy for
Surgical
Implant Applications (UNS R56700)
• ASTM F67 Standard Specification
for Unalloyed Titanium, for Surgical
Implant Applications (UNS R50250,
UNS R50400, UNS R50550, UNS
R50700)
• ASTM F138 Standard
Specification for Wrought 18
Chromium-14 Nickel-2.5
Molybdenum Stainless Steel Bar
and Wire for Surgical Implants
(UNS S31673)
• ASTM F139 Standard
Specification for Wrought 18
Chromium-14 Nickel-2.5
Molybdenum Stainless Steel Sheet
and Strip for Surgical Implants
(UNS S31673)
ASTM F1537 Standard Specification
for Wrought Cobalt-28-Chromium-6-
Molybdenum Alloys for Surgical
Implants (UNS R31537, UNS R31538,
and UNS R31539) | Note No.2,
Note No.5 |
| Mechanical
Performance | Test name: Static Four-
Point Bending
Methodology: FDA-
recognized version of
ASTM F382 Standard
Specification and
Test Method for
Metallic Bone Plates.
Test name: Driving | Test name: Static Four-Point Bending
Methodology: FDA-recognized
version of ASTM F382 Standard
Specification and Test Method for
Metallic Bone Plates. | Note No.6 |
| | torque, Torsional
strength, Axial pullout
testing
Methodology: FDA-
recognized version of
ASTM F543 Standard
Specification and Test
Methods for Metallic
Medical Bone Screws | | |
| Sterilization
(devices labeled
as sterile) and
Reprocessing
(end-user
sterilized)
Validation | Test name:
Sterilization (devices
labeled as sterile) and
Reprocessing (end-
user sterilized)
Methodology:
International
Organization for
Standardization (ISO)
17665-1 Sterilization
of health care products
- Moist heat - Part
1: Requirements for
the development,
validation, and
routine control of a
sterilization process for
medical devices | Test name: Sterilization (devices
labeled as sterile) and Reprocessing
(end-user sterilized)
Methodology: FDA currently-
recognized versions of the following
consensus standards (as applicable):
International Organization for
Standardization (ISO) 17665-1
Sterilization of health care products - Moist heat - Part 1:
Requirements for the development,
validation, and routine control of
a sterilization process for medical
devices
• ISO 11135-1 Sterilization of health
care products - Ethylene oxide – Part 1:
Requirements for development,
validation, and routine control of a
sterilization process for medical devices
• ISO 11137-1 Sterilization of health
care products - Radiation - Part 1:
Requirements for development,
validation, and routine control of a | Note No.7 |
| | | sterilization process for medical devices
Contains Nonbinding
Recommendations:
• ISO 11607-1 Packaging for terminally
sterilized medical devices – Part 1:
Requirements for materials, sterile
barrier systems and packaging systems
• ISO 11607-2 Packaging for terminally
sterilized medical devices – Part 2:
Validation requirements for
forming, sealing and assembly processes | |
| Biocompatibility
Evaluation | Test name:
Cytotoxicity test
Methodology: Use of
International Standard
ISO 10993-1,
Biological evaluation
of medical devices –
Part 1: Evaluation and
testing within a risk
management process | Test name: Biocompatibility
endpoints Methodology: Use of
International Standard ISO 10993-
1, Biological evaluation of medical
devices – Part 1: Evaluation and
testing within a risk management
process | Same |
7
8
9
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 | ||
| 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 | ||
| Systems | DOUBLE ENGINE BONE | ||
| PLATE AND SCREW | |||
| 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 |
| can be regarded as substantially equivalent. | |
| Note No.2 | The materials used in the plates are within the range of the SPBP path list |
| material and are therefore considered substantially equivalent. | |
| Note No.3 | The plate is within the SPBP path enumeration range and therefore considered |
10
| 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.