(55 days)
No
The device description focuses on mechanical components (plates and screws) and their physical properties and performance. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
This device is an implantable plate and screw system intended for internal fixation of fractures, osteotomies, nonunions, replantations, and fusions, primarily providing mechanical support rather than directly treating a disease or condition in a therapeutic manner beyond stabilization.
No
Explanation: The device is described as an implantable system of metallic plates and screws used for the fixation of bone fractures, osteotomies, nonunions, replantations, and fusions. Its purpose is to provide structural support and stability, not to diagnose medical conditions.
No
The device description explicitly states it consists of "metallic plates and screws" and describes their physical properties and materials. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as metallic plates and screws used for locking screw technology with conventional plating techniques. These are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is an implantable surgical device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, wrist, foot, ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance evaluation of the DePuy Synthes, 2.7mm LCP Plates was compared to existing DePuy Synthes, 2.7mm LCP plates regarding mechanical performance. The evaluation supports that the mechanical performance of the subject devices are at least equivalent to that of the predicate devices. Magnetic Resonance compatibility evaluation was performed to establish the MR Conditional parameters for the subject DePuy Synthes, 2.7mm LCP Plates. Endotoxin testing was performed using the LAL test method to establish that the subject DePuy Synthes 2.7mm LCP Plates meet the specified endotoxin requirement of 20EU/device. Biocompatibility evaluation and testing was 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. Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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 Synthes
1301 Goshen Parkway
West 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 | |
| Date
Prepared | May 26, 2021 | | |
| Proprietary
Name | DePuy Synthes 2.7 mm LCP Plates
(Modular Mini Fragment LCP System) | | |
| Classification
Name | Single/multiple component metallic bone fixation appliances and accessories | | |
| Classification | Class II
Regulation Number: 21 CFR 888.3030
Product Code: HRS | | |
| Predicate
device | Synthes (USA) Modular Mini Fragment LCP System (K063049) | | |
| Reference
Device A | Stryker VariAx 2 Distal Radius Plating System (K141430) | | |
| Reference
Device B | Stryker VariAx 2 Compression Plating System (K170727) | | |
| Device
Description | 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. | | |
4
K211051
| | 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. |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | 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 bones and small bone fragments, particularly in osteopenic bone. Examples
include, but are not limited to, the hand, wrist, foot, and ankle. |
| Non-clinical
Performance
Data | The non-clinical performance evaluation of the DePuy Synthes, 2.7mm LCP Plates per
this submission has been compared to the existing DePuy Synthes, 2.7mm LCP plates
with regards to mechanical performance. The evaluation supports that the mechanical
performance of the subject devices are at least equivalent to that of the predicate
devices.
Magnetic Resonance compatibility evaluation has been performed to establish the MR
Conditional parameters for the subject DePuy Synthes, 2.7mm LCP Plates.
Endotoxin testing has been performed using to the LAL test method to establish that the
subject DePuy Synthes 2.7mm LCP Plates meet the specified endotoxin requirement of
20EU/device.
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. |
| Clinical
Performance
Data | Clinical testing was not necessary for the determination of substantial equivalence. |
| Substantial
Equivalence | 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 2.7mm
Adaption Plates (Modular Mini Fragment LCP System) 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 in regards to intended
use, material, design, and operational principles.
The non-clinical performance data as well as the comparison of design features included
in this premarket notification demonstrate that any differences in technological
characteristics of the subject devices compared to the predicate devices do not raise any
new questions of safety and effectiveness.
It is concluded that the information provided herein supports substantial equivalence of
the subject devices. |