(55 days)
The DePuy Synthes 2.7 mm LCP Plates (Modular Mini Fragment LCP System) is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
The Synthes Modular Mini Fragment LCP (Locking Compression Plate) System consists of metallic plates and screws that merge locking screw technology with conventional plating techniques. Locking screws provide the ability to create a fixed-angle construct while utilizing familiar AO plating techniques. A fixed-angle construct provides improved fixation in osteopenic bone or multifragment fractures where traditional screw purchase is compromised. The subject plates are available in various sizes in sterile configurations and are available in stainless steel and commercially pure titanium. The system also consists of implantable screws (K112583) that correspond to the subject device.
This is a 510(k) premarket notification for the DePuy Synthes 2.7mm LCP Plates (Modular Mini Fragment LCP System), a metallic bone fixation appliance. The FDA determined that the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided information, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Mechanical performance equivalent to existing DePuy Synthes 2.7mm LCP plates. | The evaluation supports that the mechanical performance of the subject devices are at least equivalent to that of the predicate devices. |
| MR Compatibility | Establish MR Conditional parameters. | Magnetic Resonance compatibility evaluation has been performed to establish the MR Conditional parameters for the subject DePuy Synthes, 2.7mm LCP Plates. (Specific parameters not detailed in this document). |
| Endotoxin Content | Meet specified endotoxin requirement of 20 EU/device. | Endotoxin testing has been performed using the LAL test method to establish that the subject DePuy Synthes 2.7mm LCP Plates meet the specified endotoxin requirement of 20 EU/device. |
| Biocompatibility | Biologically safe when used as intended, in accordance with ISO 10993-1. | Biocompatibility evaluation and testing has been performed in accordance with ISO 10993-1 and it is concluded that the subject DePuy Synthes 2.7mm LCP Plates are biologically safe when used as intended. |
| Indications for Use | Align with the indications for use of the predicate device (Synthes (USA) Modular Mini Fragment LCP System (K063049)). | The subject devices fully align with the indications for use compared to the predicate. |
| Material, Design, Operation | Substantially equivalent in regards to material, design, and operational principles to predicate and reference devices. | A comparison of the subject devices... demonstrated that they are substantially equivalent to the previously cleared Synthes (USA) Modular Mini Fragment LCP System (K063049), VariAx 2 Distal Radius Plating System (K141430) and the VariAx 2 Compression Plating System (K170727) from Stryker. |
| Safety and Effectiveness | Differences in technological characteristics compared to predicate devices do not raise any new questions of safety and effectiveness. | The non-clinical performance data as well as the comparison of design features... demonstrate that any differences... do not raise any new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a "test set" in the context of clinical data for the device's performance, as clinical testing was not necessary for the determination of substantial equivalence. The studies conducted were non-clinical (mechanical, MR compatibility, endotoxin, biocompatibility). Therefore, details like data provenance (country of origin), retrospective/prospective nature, and sample size for a test set (in a clinical sense) are not applicable or provided.
For the non-clinical studies:
- Mechanical Testing: The sample size for mechanical testing is not explicitly stated. The evaluation was a comparison to existing predicate plates.
- MR Compatibility: The sample size for MR testing is not explicitly stated.
- Endotoxin Testing: The sample size for endotoxin testing is not explicitly stated, but it involved testing the subject device(s).
- Biocompatibility Testing: The sample size for biocompatibility testing is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As clinical testing was not required for substantial equivalence, there was no "ground truth" derived from expert consensus on patient data. The "ground truth" for non-clinical tests would be the established performance standards or test methods (e.g., ISO 10993-1 for biocompatibility).
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not done, as clinical testing was not deemed necessary for this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a bone fixation appliance, not an algorithm or AI-based diagnostic tool. The performance evaluated was physical and biological characteristics of the implant, not an algorithm's output.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical studies was based on established engineering principles, international standards, and regulatory requirements:
- Mechanical Performance: Comparison to the known mechanical performance of the legally marketed predicate device.
- MR Compatibility: Established guidelines for MR Conditional parameters.
- Endotoxin Testing: The specified endotoxin limit (20 EU/device) and the LAL test method.
- Biocompatibility: ISO 10993-1 series of standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical implant, not an AI model, so there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 2, 2021
DePuy Synthes Ann-Christin Ponick Senior Regulatory Affairs Specialist Luzernstrasse 21 Zuchwil, Solotburn 4528 Switzerland
Re: K211051
Trade/Device Name: DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP 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 Dated: April 1, 2021 Received: April 8, 2021
Dear Ann-Christin Ponick:
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 (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 located 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}------------------------------------------------
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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.
Shumaya Ali, M.P.H. 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K211051
Device Name
DePuy Synthes 2.7 mm LCP Plates (Modular Mini Fragment LCP System)
Indications for Use (Describe)
The DePuy Synthes 2.7 mm LCP Plates (Modular Mini Fragment LCP System) is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
| Sponsor | DePuy Synthes1301 Goshen ParkwayWest Chester, PA, 19380 | ||
|---|---|---|---|
| Primary Contact: | Alternate Contact: | ||
| Ann-Christin Ponick | Stacey Bonnell | ||
| Senior Regulatory Affairs Specialist | Director, Regulatory Affairs | ||
| DePuy Synthes | DePuy Synthes | ||
| Luzernstrasse 21 | 1301 Goshen Parkway | ||
| 4528 Zuchil, Switzerland | West Chester, PA, 19380 | ||
| Phone: +41 79 585- 1916 | Phone: (484) 238 —7519 | ||
| E-Mail: aponick@its.jnj.com | E-Mail: sbonnell@its.jnj.com | ||
| DatePrepared | May 26, 2021 | ||
| ProprietaryName | DePuy Synthes 2.7 mm LCP Plates(Modular Mini Fragment LCP System) | ||
| ClassificationName | Single/multiple component metallic bone fixation appliances and accessories | ||
| Classification | Class IIRegulation Number: 21 CFR 888.3030Product Code: HRS | ||
| Predicatedevice | Synthes (USA) Modular Mini Fragment LCP System (K063049) | ||
| ReferenceDevice A | Stryker VariAx 2 Distal Radius Plating System (K141430) | ||
| ReferenceDevice B | Stryker VariAx 2 Compression Plating System (K170727) | ||
| DeviceDescription | The Synthes Modular Mini Fragment LCP (Locking Compression Plate) System consistsof metallic plates and screws that merge locking screw technology with conventionalplating techniques. Locking screws provide the ability to create a fixed-angle constructwhile utilizing familiar AO plating techniques. A fixed-angle construct provides improvedfixation in osteopenic bone or multifragment fractures where traditional screw purchase iscompromised. |
{4}------------------------------------------------
K211051
| The subject plates are available in various sizes in sterile configurations and areavailable in stainless steel and commercially pure titanium.The system also consists of implantable screws (K112583) that correspond to the subjectdevice. | |
|---|---|
| Indicationsfor use | The DePuy Synthes 2.7 mm LCP Plates (Modular Mini Fragment LCP System) isintended for fixation of fractures, osteotomies, nonunions, replantations, and fusions ofsmall bones and small bone fragments, particularly in osteopenic bone. Examplesinclude, but are not limited to, the hand, wrist, foot, and ankle. |
| Non-clinicalPerformanceData | The non-clinical performance evaluation of the DePuy Synthes, 2.7mm LCP Plates perthis submission has been compared to the existing DePuy Synthes, 2.7mm LCP plateswith regards to mechanical performance. The evaluation supports that the mechanicalperformance of the subject devices are at least equivalent to that of the predicatedevices.Magnetic Resonance compatibility evaluation has been performed to establish the MRConditional parameters for the subject DePuy Synthes, 2.7mm LCP Plates.Endotoxin testing has been performed using to the LAL test method to establish that thesubject DePuy Synthes 2.7mm LCP Plates meet the specified endotoxin requirement of20EU/device.Biocompatibility evaluation and testing has been performed in accordance with ISO10993-1 and it is concluded that the subject DePuy Synthes 2.7mm LCP Plates arebiologically safe when used as intended. |
| ClinicalPerformanceData | Clinical testing was not necessary for the determination of substantial equivalence. |
| SubstantialEquivalence | The subject devices fully align with the indications for use compared to the predicate,Synthes (USA) Modular Mini Fragment LCP System (K063049).A comparison of the subject devices DePuy Synthes 2.7mm Straight and 2.7mmAdaption Plates (Modular Mini Fragment LCP System) demonstrated that they aresubstantially equivalent to the previously cleared Synthes (USA) Modular Mini FragmentLCP System (K063049), VariAx 2 Distal Radius Plating System (K141430) and theVariAx 2 Compression Plating System (K170727) from Stryker in regards to intendeduse, material, design, and operational principles.The non-clinical performance data as well as the comparison of design features includedin this premarket notification demonstrate that any differences in technologicalcharacteristics of the subject devices compared to the predicate devices do not raise anynew questions of safety and effectiveness.It is concluded that the information provided herein supports substantial equivalence ofthe subject devices. |
§ 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.