(308 days)
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.
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.
This document from the FDA is a 510(k) clearance letter for a medical device called "Locking Plates and Screws Systems". It determines that the device is substantially equivalent to legally marketed predicate devices. The document details the device's indications for use, technological characteristics, and results of non-clinical testing to support its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a table labeled "acceptance criteria" against "reported device performance" in a quantitative manner as one might expect for a digital diagnostic device. However, it implicitly uses the Safety and Performance Based Pathway (SPBP) criteria and comparison to predicate devices as its acceptance framework, with compliance to recognized standards as the performance measure.
Here's a reconstructed table based on the provided text, focusing on the mechanical performance aspects:
| Acceptance Criteria (from SPBP or Predicate) | Reported Device Performance (Subject Device) | SE Discussion (Performance Met) |
|---|---|---|
| Mechanical Performance: | ||
| Static Four-Point Bending (ASTM F382) | Test conducted according to FDA-recognized ASTM F382 | Test results meet SPBP path requirements or are similar to predicate device results (Note No.6) |
| Driving Torque (ASTM F543) | Test conducted according to FDA-recognized ASTM F543 | Test results meet SPBP path requirements or are similar to predicate device results (Note No.6) |
| Torsional Strength (ASTM F543) | Test conducted according to FDA-recognized ASTM F543 | Test results meet SPBP path requirements or are similar to predicate device results (Note No.6) |
| Axial Pullout Testing (ASTM F543) | Test conducted according to FDA-recognized ASTM F543 | Test results meet SPBP path requirements or are similar to predicate device results (Note No.6) |
| Material: | ||
| Plates: Within SPBP path list material (e.g., ASTM F67, F136, F1472, F1295, F138, F139, F1537) | TA3G conforms to ASTM F67; TC4 conforms to ASTM F136 | Materials used are within the SPBP path list (Note No.2) |
| Screws: Within SPBP path enumerated material range | TC4 conforms to ASTM F136 | Materials used for bone screws are within the SPBP path enumerated material range (Note No.5) |
| Sterilization: | ||
| Sterilization parameters within SPBP path listing criteria (e.g., ISO 17665-1, ISO 11135-1, ISO 11137-1) | Sterilization Validation testing conducted according to ISO 17665-1 | Source criteria for recommended sterilization parameters are within SPBP path listing criteria (Note No.7) |
| Biocompatibility: | ||
| Biocompatibility endpoints according to ISO 10993-1 | Cytotoxicity test conducted according to ISO 10993-1 | Same (Biocompatibility Evaluation) |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes for the non-clinical mechanical performance tests (e.g., number of plates or screws tested). It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective) as these are non-clinical, in-vitro tests on the device itself, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the evaluation is based on non-clinical, in-vitro mechanical and material testing, not on clinical data requiring expert human assessment for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable for the same reason mentioned in point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device (Locking Plates and Screws Systems) is a mechanical orthopedic implant, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical medical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this device, the "ground truth" for the non-clinical testing is based on:
- Engineering standards and specifications: Mechanical properties are evaluated against established ASTM standards (F382, F543) and parameters defined by the Safety and Performance Based Pathway.
- Material specifications: Material composition is verified against ASTM standards (F67, F136).
- Sterilization standards: Sterilization efficacy is assessed against ISO 17665-1.
- Biocompatibility standards: Biocompatibility is evaluated against ISO 10993.
These standards serve as the objective "ground truth" to determine if the device performs as expected and is safe.
8. The sample size for the training set:
This is not applicable as the device is a physical medical implant and does not involve machine learning models that require training data.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this type of device.
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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 (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
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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 DevelopmentZone, 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
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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-ClinicalTesting | Mechanical Performance Testing was conducted according to ASTM F543and ASTM F382. Driving torque, torsional strength, and axial pullouttesting were conducted on the subject and predicate device screwsaccording to ASTM F543. Four-point bend testing was conducted on thesubject and predicate device plates according to ASTM F382.Sterilization Validation testing was conducted according to InternationalOrganization for Standardization (ISO) 17665-1: Sterilization of healthcare 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
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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 DeviceLocking Plates andScrews Systems | Orthopedic Fracture Fixation Plates– Performance Criteria for Safety andPerformance Based Pathway andOrthopedic Non-Spinal Metallic BoneScrews and Washers - PerformanceCriteria for Safety and PerformanceBased Pathway | SEDiscussion |
|---|---|---|---|
| Product Code | HRS | HRS | Same |
| Regulation No. | 21 CFR 888.3030 | 21 CFR 888.3030 | Same |
| Intended Use | Locking Plates andScrews Systems isintended to providefixation duringfractures, fusions, andosteotomies. LockingPlates and ScrewsSystems is indicatedfor the clavicle, andsmall bones includingthe metacarpals, wrist,metatarsals, tarsals andphalanges, and longbones including theradius, ulna, humerus,olecranon, fibula,femur, and tibia. | The fracture fixation plates that fallwithin the scope of this guidancedocument are intended forosteosynthesis (i.e., rigid fixation ofopposing bone fragments for fracturefixation, osteotomy, or arthrodesis). | Note No.1,Note No.4 |
| Material | |||
| TA3G conforms toASTM F67 and TC4conforms to ASTMF136 | • ASTM F136 StandardSpecification for WroughtTitanium-6 Aluminum-4 VanadiumELI (Extra Low Interstitial) Alloyfor Surgical Implant Applications(UNS R56401)• ASTM F1472 StandardSpecification for Wrought Titanium-6Aluminum -4Vanadium Alloy forSurgical Implant Applications(UNS R56400)• ASTM F1295 StandardSpecification for Wrought Titanium-6 Aluminum-7Niobium Alloy forSurgicalImplant Applications (UNS R56700)• ASTM F67 Standard Specificationfor Unalloyed Titanium, for SurgicalImplant Applications (UNS R50250,UNS R50400, UNS R50550, UNSR50700)• ASTM F138 StandardSpecification for Wrought 18Chromium-14 Nickel-2.5Molybdenum Stainless Steel Barand Wire for Surgical Implants(UNS S31673)• ASTM F139 StandardSpecification for Wrought 18Chromium-14 Nickel-2.5Molybdenum Stainless Steel Sheetand Strip for Surgical Implants(UNS S31673)ASTM F1537 Standard Specificationfor Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for SurgicalImplants (UNS R31537, UNS R31538,and UNS R31539) | Note No.2,Note No.5 | |
| MechanicalPerformance | Test name: Static Four-Point BendingMethodology: FDA-recognized version ofASTM F382 StandardSpecification andTest Method forMetallic Bone Plates.Test name: Driving | Test name: Static Four-Point BendingMethodology: FDA-recognizedversion of ASTM F382 StandardSpecification and Test Method forMetallic Bone Plates. | Note No.6 |
| torque, Torsionalstrength, Axial pullouttestingMethodology: FDA-recognized version ofASTM F543 StandardSpecification and TestMethods for MetallicMedical Bone Screws | |||
| Sterilization(devices labeledas sterile) andReprocessing(end-usersterilized)Validation | Test name:Sterilization (deviceslabeled as sterile) andReprocessing (end-user sterilized)Methodology:InternationalOrganization forStandardization (ISO)17665-1 Sterilizationof health care products- Moist heat - Part1: Requirements forthe development,validation, androutine control of asterilization process formedical devices | Test name: Sterilization (deviceslabeled as sterile) and Reprocessing(end-user sterilized)Methodology: FDA currently-recognized versions of the followingconsensus standards (as applicable):International Organization forStandardization (ISO) 17665-1Sterilization of health care products- Moist heat - Part 1:Requirements for the development,validation, and routine control ofa sterilization process for medicaldevices• ISO 11135-1 Sterilization of healthcare products - Ethylene oxide – Part 1:Requirements for development,validation, and routine control of asterilization process for medical devices• ISO 11137-1 Sterilization of healthcare products - Radiation - Part 1:Requirements for development,validation, and routine control of a | Note No.7 |
| sterilization process for medical devicesContains NonbindingRecommendations:• ISO 11607-1 Packaging for terminallysterilized medical devices – Part 1:Requirements for materials, sterilebarrier systems and packaging systems• ISO 11607-2 Packaging for terminallysterilized medical devices – Part 2:Validation requirements forforming, sealing and assembly processes | |||
| BiocompatibilityEvaluation | Test name:Cytotoxicity testMethodology: Use ofInternational StandardISO 10993-1,Biological evaluationof medical devices –Part 1: Evaluation andtesting within a riskmanagement process | Test name: Biocompatibilityendpoints Methodology: Use ofInternational Standard ISO 10993-1, Biological evaluation of medicaldevices – Part 1: Evaluation andtesting within a risk managementprocess | 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 ScrewsSystems | 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 ScrewsSystems | DOUBLE ENGINE BONEPLATE AND SCREWSYSTEMS | 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 andcan be regarded as substantially equivalent. |
| Note No.2 | The materials used in the plates are within the range of the SPBP path listmaterial 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.
N/A