(247 days)
The Signature Osteosynthesis Plate System is intended for adult patients for internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions. The 1/3 Tubular Plate and Compression Plate Small are internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions of the Foot, hand, wrist, and forearm. Additionally, the Compression Plate Narrow and Compression Plate Broad are internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions of the upper extremity and lower extremity, except for the femur and proximal tibia. The Clavicle Plates are intended for use in fixation of fractures, osteotomies, and non-unions of the clavicle in adult patients in whom the clavicular growth plates have fused or in whom the growth plates can be crossed by the plate system.
The Signature Osteosynthesis Plate System utilizes screws and plates of various lengths and designs to accommodate a variety of patient anatomies. The System utilizes medical grade Titanium alloy. System implants are provided both sterile and non-sterile with instructions for steam sterilization. The sterile implants are provided sterilized in Tyvek packaging. The implants are single use only.
This document describes the regulatory clearance for the Signature Osteosynthesis Plate System. It is a medical device for internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions in adult patients.
Here's an analysis of the provided text with respect to acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum tensile strength of X MPa). Instead, it states that the device's strength is "sufficient for their intended use and substantially equivalent to legally marketed predicate devices." The performance data are presented as test modes, and the conclusion refers to the device being "at least as safe and effective" as predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical strength sufficient for intended use | Static Four-point Bending (per ASTM F382-99 (2008)): Passed |
| Mechanical strength substantially equivalent to predicate devices | Dynamic Four-point Bending (per ASTM F382-99 (2008)): Passed |
| Static Torsion (per ASTM F543-13): Passed | |
| Static Axial Pullout (per ASTM F543-13): Passed | |
| Biocompatibility and sterility | System utilizes medical grade Titanium alloy; provided sterile and non-sterile with instructions for steam sterilization. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not specify the sample size used for each of the non-clinical tests (Static Four-point Bending, Dynamic Four-point Bending, Static Torsion, Static Axial Pullout).
- Data Provenance: The data are non-clinical (mechanical testing) and therefore do not have a country of origin in the context of patient data. The tests were performed according to ASTM standards, which are international standards. The study is non-clinical.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: This information is not applicable as the study is a non-clinical, mechanical testing study, not a clinical study involving human expert interpretation for ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set
- Adjudication Method: This is not applicable as the study is a non-clinical, mechanical testing study. Adjudication methods are typically used in clinical trials involving human interpretations or outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done?: No. The document explicitly states: "Clinical data and conclusions were not needed for this device." The study was entirely non-clinical (mechanical testing).
- Effect Size with AI vs without AI: Not applicable, as no MRMC study or AI component is mentioned.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done?: No. This device is a physical orthopedic implant, not a software algorithm or AI-powered diagnostic tool. Therefore, a standalone performance study in the context of an algorithm is not relevant. The performance studies conducted were mechanical tests of the physical device.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's performance is established by the compliance with specific ASTM (American Society for Testing and Materials) standards for mechanical properties. The test results are compared against the requirements of these standards and against the performance of legally marketed predicate devices. This falls under engineering standards and comparative performance data.
8. Sample Size for the Training Set
- Sample Size for Training Set: This is not applicable. The device is a physical implant, not a machine learning model, so there is no "training set."
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 6, 2025
Signature Orthopaedic Pty Ltd. % Jared Walkenhorst Consultant Novare Medical Consulting 1765 Dusty Boot Drive Lafayette, Colorado 80026
Re: K241599
Trade/Device Name: Signature Osteosynthesis Plate 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: January 29, 2025 Received: January 29, 2025
Dear Jared Walkenhorst:
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 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,
Thomas Mcnamara -S
For: Christopher Ferriera, MS 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
The Signature Osteosynthesis Plate System
Indications for Use (Describe)
The Signature Osteosynthesis Plate System is intended for adult patients for internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions. The 1/3 Tubular Plate and Compression Plate Small are internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions of the Foot, hand, wrist, and forearm. Additionally, the Compression Plate Narrow and Compression Plate Broad are internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions of the upper extremity and lower extremity, except for the femur and proximal tibia. The Clavicle Plates are intended for use in fixation of fractures, osteotomies, and non-unions of the clavicle in adult patients in whom the clavicular growth plates have fused or in whom the growth plates can be crossed by the plate system.
Type of Use (Select one or both, as applicable)
X 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/1 description: The image shows the logo for Signature Orthopaedics. The logo features a green circle with a white silhouette of a person bending over inside. To the right of the circle is the word "Signature" in a cursive green font, with the word "ORTHOPAEDICS" in smaller, block letters underneath.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Sponsor: | Signature Orthopaedic Pty Ltd.7 Sirius Rd Lane Cove West, NSW 2066Sydney, Australia |
|---|---|
| Submitter's Phone: | +61 2 9428 5181 |
| Submitter Contact: | Dr. Declan Brazildeclan.brazil@signatureortho.com.au |
| Contact Person: | Mr. Jared Walkenhorst720-215-9244Novare Medical llc, Consultant |
| Date: | January 29, 2025 |
| Trade Name: | Signature Osteosynthesis Plate System |
| Classification ProductCode: | HRS, HWC |
| Device CommonName: | Plate, fixation, boneScrew, fixation, bone |
| Regulation Number /Description: | 21 CFR § 888.3030 Single/multiple component metallic bone fixationappliances and accessories21 CFR § 888.3040 Smooth or threaded metallic bone fixationfastener |
| Predicate Device(s): | K171320 |
| Device Description: | The Signature Osteosynthesis Plate System utilizes screws and platesof various lengths and designs to accommodate a variety of patientanatomies. The System utilizes medical grade Titanium alloy. Systemimplants are provided both sterile and non-sterile with instructions forsteam sterilization. The sterile implants are provided sterilized inTyvek packaging. The implants are single use only. |
| IntendedUse/Indications for use: | The Signature Osteosynthesis Plate System is intended for adultpatients for internal fixation and stabilization of fractures,osteotomies, malunions, and non-unions. The 1/3 Tubular Plate andCompression Plate Small are intended for internal fixation andstabilization of fractures, osteotomies, malunions, and non-unions ofthe Foot, hand, wrist, and forearm. Additionally, the CompressionPlate Narrow and Compression Plate Broad are intended for internalfixation and stabilization of fractures, osteotomies, malunions, andnon-unions of the upper extremity and lower extremity, except for thefemur and proximal tibia. The Clavicle Plates are intended for use infixation of fractures, osteotomies, and non-unions of the clavicle inadult patients in whom the clavicular growth plates have fused or inwhom the growth plates can be crossed by the plate system. |
| TechnologicalCharacteristicsComparison toPredicate Device(s): | The subject and predicate devices have nearly identical technologicalcharacteristics and the minor differences do not raise any new issuesof safety and effectiveness. Specifically the following characteristicsare similar between the subject and predicates:Indications for use Materials of manufacture Structural support mechanism Principle of operation Sizes |
| Performance Data(Nonclinical and/orClinical): | The Signature Osteosynthesis Plate System have been tested in the following test modes: Static Four-point Bending per ASTM F382-99 (2008) Dynamic Four-point Bending per ASTM F382-99 (2008) Static Torsion per ASTM F543-13 Static Axial Pullout per ASTM F543-13 The results of this non-clinical testing show that the strength of the Signature Osteosynthesis Plate System is sufficient for their intended use and substantially equivalent to legally marketed predicate devices.Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device. |
| Conclusion: | The subject devices have the same intended use and same indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design and labeling and are manufactured and sterilized using the same materials and processes as the predicate devices.Any differences do not raise new questions of safety and effectiveness as established with performance testing; The subject devices are at least as safe and effective as the legally marketed predicate devices. |
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Image /page/5/Picture/1 description: The image shows the logo for Signature Orthopaedics. The logo features a green circle with a white figure inside, resembling a person bending over. To the right of the circle is the word "Signature" in a cursive, green font, with the word "ORTHOPAEDICS" in smaller, block letters underneath.
§ 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.