(27 days)
Not Found
No
The device description and intended use focus on mechanical fixation of clavicle fractures using plates and screws. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is a medical implant (plate system) used for the fixation of clavicle fractures and dislocations, which directly treats an injury and restores function.
No
This device is a plate system indicated for the fixation of fractures and nonunions of the clavicle, making it a therapeutic or orthopedic fixation device, not a diagnostic one.
No
The device description explicitly details physical implants (plates) made of stainless steel and titanium alloy, as well as non-implantable templates. There is no mention of software as the primary or sole component of the device.
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, and fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. This is a surgical intervention on the body.
- Device Description: The device consists of plates and templates designed for surgical implantation and size selection. These are physical implants and tools 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 screening.
IVD devices are used outside the body to analyze samples. This device is used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The DePuy Synthes 2.7mm VA LCP Clavicle 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.
The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
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.
The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System consists of the plate types Long, Short and Button which can be used to treat simple and complex clavicle fractures including malunions, non- unions and isolated ligamentous injuries of the AC joint. The subject plates are available in three hook depths, in left- and right-side versions, in both sterile and non-sterile configurations and are available in stainless steel and titanium. The system also consists of non- implantable templates that correspond to the implants. Templates are intended for implant size selection and are available non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Clavicle, Acromioclavicular joint
Indicated Patient Age Range
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.
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)
Non-clinical performance data was not necessary for the determination of substantial equivalence.
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.
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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 16, 2020
DePuy Synthes % Georgina Mueller Regulatory Affairs Specialist II Synthes GmbH Luzernstrasse 21 Zuchwil. SO 4528 Switzerland
Re: K203414
Trade/Device Name: DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook 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: November 16, 2020 Received: November 19, 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 (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 Stereotaxic, Trauma and Restorative 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
510(k) Number (if known) K203414
Device Name
DePuy Synthes 2.7mm VA LCP Clavicle Plate System
Indications for Use (Describe)
The DePuy Synthes 2.7mm VA LCP Clavicle 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.
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."
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Indications for Use
510(k) Number (if known) K203414
Device Name
DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
Indications for Use (Describe)
The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
Type of Use (Select one or both, as applicable)
| ü Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------- |
| X 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."
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510(k) Summary
DePuy Synthes 2.7mm VA LCP Clavicle Plate System
| Sponsor | DePuy Synthes
Georgina Mueller
1301 Goshen Parkway
West Chester, PA 19380
Phone: +41 61 965 63 14 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | November 16, 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 |
| Predicate device | DePuy Synthes 2.7mm VA LCP Clavicle Plate System (K201321) |
| 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 device remain
unchanged compared to the previously cleared version of this device
cleared via K201321 (predicate device). |
| Non-clinical Performance
Data | Non-clinical performance data was not necessary for the determination
of substantial equivalence. |
| Clinical Performance Data | Clinical testing was not necessary for the determination of substantial
equivalence. |
| Substantial Equivalence | The following subject device characteristics remain unchanged
compared to the previously cleared version of these devices
(predicate):
- 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. - Indicated for 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. - Design, features, and specifications (technological characteristics)
The subject devices have added contraindications compared to the
predicate devices which has no contraindications. The differences in
contraindications 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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DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
| Sponsor | DePuy Synthes
Georgina Mueller
1301 Goshen Parkway
West Chester, PA 19380
Phone: +41 61 965 63 14 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | November 16, 2020 |
| Proprietary Name | DePuy Synthes 2.7mm VA LCP Clavicle Hook 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 |
| Predicate device | DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System (K201959) |
| Device Description | The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
consists of the plate types Long, Short and Button which can be used |
| | to treat simple and complex clavicle fractures including malunions, non- unions and isolated ligamentous injuries of the AC joint. The subject plates are available in three hook depths, in left- and right-side versions, in both sterile and non-sterile configurations and are available in stainless steel and titanium. The system also consists of non- implantable templates that correspond to the implants. Templates are intended for implant size selection and are available non-sterile. |
| Indications for use | The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. |
| Technological Characteristics | The design, features, and specifications of the subject device remain unchanged compared to the previously cleared version of this device cleared via K201959 (predicate device). |
| Non-clinical Performance
Data | Non-clinical performance data was not necessary for the determination of substantial equivalence. |
| Clinical Performance Data | Clinical testing was not necessary for the determination of substantial equivalence. |
| Substantial Equivalence | The following subject device characteristics remain unchanged compared to the previously cleared version of these devices (predicate): Intended for the use in fixation of the clavicle and the acromioclavicular joint during open reduction internal fixation (ORIF) performed by surgeons within a health care facility. Subject plates are available sterile and nonsterile, whereas the predicate plates are available sterile only. Sterile plates are sterilized by gamma irradiation. Indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. Design, features, and specifications (technological characteristics) The subject devices have revised contraindications compared to the compared to the predicate device. The differences in contraindications 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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