(67 days)
Not Found
No
The summary describes a mechanical plate system for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is used for fixation of fractures and nonunions of the clavicle, which directly treats a medical condition.
No
Explanation: The device is described as a system for temporary fixation, correction, or stabilization of clavicle bones, indicated for fractures and nonunions of the clavicle. It is an orthopedic implant designed for treatment, not for diagnosing a condition.
No
The device description clearly states it consists of physical plates made of stainless steel and titanium alloy, as well as non-implantable templates. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures and nonunions of the clavicle. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates designed for temporary fixation, correction, or stabilization of bones. These are implants used in surgery.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
This device is clearly an implantable surgical device, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The DePuy Synthes 2.7mm VA LCP Clavice Plate System is indicated for fixation of fractures, and nonunions of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The DePuy Synthes 2.7mm VA LCP Clavicle Plate System consists of lateral, shaft and medial plates designed for temporary fixation, correction or stabilization of clavicle bones. The subject plates are available in various sizes in both sterile and non-sterile configurations and are available in stainless steel and titanium alloy. The system also consists of non-implantable templates that correspond to the implants. Templates are intended for implant size selection and are available in non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle bones
Indicated Patient Age Range
adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years)
Intended User / Care Setting
surgeons within a health care facility
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)
Static and cyclic mechanical testing of constructs has been performed to compare the subject DePuy Synthes 2.7mm VA LCP Clavicle Plates to the predicate DePuy Synthes 3.5mm LCP Reconstruction Plates. This information supports that the mechanical performance of the subject devices is at least equivalent to that of the predicate devices.
Magnetic Resonance compatibility testing has been performed to establish MR Conditional parameters for the subject DePuy Synthes 2.7mm VA LCP Clavicle Plates.
Endotoxin testing has been performed using to the LAL test method to establish that the sterile subject DePuy Synthes 2.7mm VA LCP Clavicle 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 VA LCP Clavicle 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.
Synthes LCP Reconstruction Plate 3.5 (K000684), Synthes 3.5mm LCP Clavicle Plate System (K111540)
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.
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the date July 24, 2020. The text is written in a clear, sans-serif font. The date is presented in a standard format, with the month, day, and year clearly indicated.
Image /page/0/Picture/1 description: The image shows a logo with a stylized graphic on the left and the word "ADMINISTRATION" in blue text on the right. The graphic on the left appears to be a seal or emblem, possibly representing a government agency or organization. The word "ADMINISTRATION" is written in a clear, sans-serif font, making it easily readable.
DePuy Synthes % Georgina Mueller Regulatory Affairs Specialist II Synthes GMBH Luzernstrasse 21 Zuchwil. SO 4528 Switzerland
Re: K201321
Trade/Device Name: DePuv Synthes 2.7mm VA LCP Clavicle 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 Dated: May 13, 2020 Received: May 18, 2020
Dear Georgina Mueller:
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.
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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 (OS) 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
DePuy Synthes 2.7mm VA LCP Clavicle Plate System
Indications for Use (Describe)
The DePuy Synthes 2.7mm VA LCP Clavice Plate System is indicated for fixation of fractures, and nonunions of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
| 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.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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510(k) Summary
| Sponsor | DePuy Synthes
Georgina Mueller
1301 Goshen Parkway
West Chester, PA 19380
Phone: +41 61 965 63 14 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | July 21, 2020 |
| Proprietary
Name | DePuy Synthes 2.7mm VA LCP Clavicle Plate System |
| Classification
Name | Single/multiple component metallic bone fixation appliances and accessories |
| Classification | Class II
Regulation Number: 21 CFR 888.3030
Product Code: HRS |
| Primary
predicate device | Synthes LCP Reconstruction Plate 3.5 (K000684) |
| Secondary
predicate device | Synthes 3.5mm LCP Clavicle Plate System (K111540) |
| Device
Description | The DePuy Synthes 2.7mm VA LCP Clavicle Plate System consists of lateral, shaft and
medial plates designed for temporary fixation, correction or stabilization of clavicle bones.
The subject plates are available in various sizes in both sterile and non-sterile configurations
and are available in stainless steel and titanium alloy. The system also consists of non-
implantable templates that correspond to the implants. Templates are intended for implant
size selection and are available in non-sterile. |
| Indications for
use | Fixation of fractures, osteotomies, and non-unions of the clavicle in adults, and in both
adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular
growth plates have fused or in which the growth plates will not be crossed by the plate system. |
| Technological
Characteristics | The design, features, and specifications of the subject and predicate devices are compared below.
The range of lengths and widths of the subject devices are similar to those offered in the predicate devices. The subject plates are slightly thinner than the predicate plates. The materials of both the subject and predicate devices are the same for plates offered in stainless steel (i.e. 316L). The materials of the subject and primary predicate plates are similar; i.e. titanium alloy (TAN) and commercially pure Titanium, respectively. The materials for the subject and secondary predicate plates are the same, i.e. TAN. Subject and predicate plates feature Locking and Compression Technology (LCP) and subject plates additionally feature Variable Angle (VA) technology to allow insertion of screws up to 15° angulation in addition to nominal angulation, whereas the predicate plates feature Locking Technology (LCP) only at nominal angulation. The subject and predicate plates have varying screw holes; in number, type and diameter. The subject plates have Variable Angle locking and Combi holes whereas the predicate plates have Locking holes and Combi holes. The subject plate screw holes are 2.7mm diameter whereas the predicate plate screw holes are 3.5mm diameter. All plates are compatible with Cortex Screws to ensure axial and plate-to-bone compression and with screws using locking technology to ensure angular stable fixation. Additional compatible screw types vary for subject (VA Locking, Metaphyseal) and |
| | predicate (Locking, Cancellous) plates, as do the screw diameters for subject plates
(2.7mm) and predicate plates (3.5mm, 2.7mm, 2.4mm and 4.0mm). |
| | • Subject (Lateral and Shaft) and secondary predicate plates (Superior) feature K-wire
holes for temporary fixation, whereas subject (Medial) and primary predicate plates do
not feature suture or K-wire holes. Subject plates (Lateral) feature suture holes, which are
not featured in either of the predicate plates.
• Subject and secondary predicate plates are pre-contoured to accommodate for anatomical
differences and available as mirrored plates dedicated for the left and right clavicle.
Primary predicate plates are straight and can be used for left and right clavicle. All plates
can be contoured intra-operatively and notches are featured to facilitate plate bending.
• Subject plates and secondary predicate plates have a low-profile design to help avoid
potential for soft tissue irritation and feature tapered tips (edges) to facilitate plate
insertion. Primary predicate plates do not feature low-profile design or tapered tips
(edges). |
| Non-clinical
Performance
Data | Static and cyclic mechanical testing of constructs has been performed to compare the subject
DePuy Synthes 2.7mm VA LCP Clavicle Plates to the predicate DePuy Synthes 3.5mm LCP
Reconstruction Plates. This information supports that the mechanical performance of the
subject devices is at least equivalent to that of the predicate devices. |
| | Magnetic Resonance compatibility testing has been performed to establish MR Conditional
parameters for the subject DePuy Synthes 2.7mm VA LCP Clavicle Plates. |
| | Endotoxin testing has been performed using to the LAL test method to establish that the sterile
subject DePuy Synthes 2.7mm VA LCP Clavicle 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 VA LCP Clavicle Plates are
biologically safe when used as intended. |
| Clinical
Performance
Data | Clinical testing was not necessary for the determination of substantial equivalence. |
| Substantial
Equivalence | Both the subject and the predicate devices are intended for the use in temporary fixation,
correction or stabilization of clavicle bones during open reduction internal fixation (ORIF)
performed by surgeons within a health care facility. Plates are available sterile and non-
sterile. Sterile plates are sterilized by gamma irradiation. |
| | The subject devices have similar indications to the primary predicate and fully align with
the indications of the secondary predicate: fixation of fractures, osteotomies, and non-unions
of the clavicle. The subject devices' patient target population includes both adolescence and
adults consistent with the secondary predicate devices. No new issues of safety and
effectiveness for the subject devices have been identified compared to the predicate devices. |
| | The non-clinical performance data as well as the comparison of indications and 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. |
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