(267 days)
No
The document describes mechanical implants for fracture stabilization and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
These devices are intended to augment fracture stabilization with plates, providing mechanical support rather than a therapeutic effect.
No
The device is intended for augmenting fracture stabilization and providing a guide for cerclage cable positioning and crimping, which are therapeutic and positioning functions, not diagnostic.
No
The device description clearly details physical components made of implant quality stainless steel and titanium, intended for surgical implantation and use with other hardware like plates and cables/wires. There is no mention of software as a component of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the devices as being used in vivo (within the body) to augment fracture stabilization with plates during surgery. This is a surgical implant/accessory, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details the physical design and how the devices are used in conjunction with plates and cables/wires on the bone. This further confirms their role as surgical implants/accessories.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro (outside the body), or providing diagnostic information based on such analysis.
The device is a surgical implant/accessory used in orthopedic procedures.
N/A
Intended Use / Indications for Use
The DePuy Synthes 5.0mm and 7.3mm Crimp Positioning Pins are intended for use with multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
The 5.0mm Crimp Positioning Pins are designed for use in the 5.0mm LCP holes of Synthes plates. The 7.3mm Crimp Positioning Pins are designed for use in the 7.3mm locking holes of Synthes plates.
The DePuy Synthes Variable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant.
The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws.
The DePuy Synthes Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
The Wire Mount is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. The Wire Mount (and cerclage wire) can be used with a variety of plates that include, but are not limited to the following. Dynamic Hip Screw (DHS) Plates, Dynamic Condylar Screw (DCS) Plates, Condylar Buttress Plates, Hook Plates, 4.5 mm Narrow and Broad Dynamic Compression Plates (DCP), 90° Child and Adolescent Osteotomy Plates, 110-130° Adult Osteotomy Plates, and 95° Condylar and 130° Angle Blade Plates (both including small stature plates).
The DePuy Synthes Cerclage Positioning Pins are intended for use with cerclage monofilament wire and multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
Cerclage Positioning Pins are designed for use with plates having locking compression or dynamic compression screw holes that accept a 3.5 mm or 4.5 mm bone screws. The Cerclage Positioning Pin (and cerclage wire or cable) can be used with a variety of Synthes plates.
Product codes (comma separated list FDA assigned to the subject device)
JDQ
Device Description
The DePuy Synthes 5.0 mm and 7.3 mm Crimp Positioning Pins are designed to fit into the screw holes of existing DePuy Synthes fixation plates for the purpose of providing a guide for Cerclage cable positioning as well as a crimping point for Cerclage cable tension fixation. The Crimp Positioning pins are available in versions composed of implant quality stainless steel and titanium.
The VA 5.0 Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0mm variable angle bone screws. Positioning or cerclage pins are intended for use with cerclage monofilament wire or multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant.
The Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates when use of screws is contraindicated, as in the presence of intramedullary implants. The design is a "T" post with a hole perpendicular to the post axis, and a small triangular ridge on the bottom. Placing the post through the dynamic compression screw hole, inserting from the bone side of the plate, creates a stable structure for cerclage wire fixation. The cerclage wire is passed around the bone, through the wire mount hole above the outer surface of the plate, and then twisted with the opposite wire end.
The design of the cerclage positioning pin is an oval body with a hole running perpendicular to the long axis (for use in compression holes), and has a stud protruding from the bottom. By placing the post through the top of the dynamic compression screw hole into a pre-drilled hole in cortical bone a stable structure is created for cerclage wire or cable fixation. The wire or cable is passed around the bone, through the Cerclage Positioning Pin hole above the outer plate surface, and then the wire is twisted or cable is crimped for final securement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone
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 testing is provided to support the conditional safety of the DePuy Synthes 5.0 mm and 7.3 mm Crimp Positioning Pins in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Variable Angle Positioning Pins in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Wire Mount construct in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.
Non-clinical testing is provided to support the conditional safety of the Synthes Cerclage Positioning Pin construct in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.
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.
K081205, K162124, K953777, K992891
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
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Synthes (USA) Products LLC/DePuy Orthopaedics Inc Suchitra Basu Global Strategy Manager, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380
June 21, 2018
Re: K172975
Trade/Device Name: DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins - MR Conditional, DePuy Synthes Variable Angle Positioning Pins - MR Conditional, DePuy Synthes Wire Mount - MR Conditional, DePuy Synthes Cerclage Positioning Pin - MR Conditional Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ Dated: May 11, 2018 Received: May 14, 2018
Dear Suchitra Basu:
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. 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.
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); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for DePuy Synthes. The logo consists of a geometric shape on the left and the text "DePuy Synthes" on the right. The geometric shape is a sphere made up of several smaller shapes. The text is in a sans-serif font, with "DePuy" in a darker blue and "Synthes" in a lighter blue.
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) K172975
Device Name
DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins - MR Conditional
Indications for Use (Describe)
The DePuy Synthes 5.0mm and 7.3mm Crimp Positioning Pins are intended for use with multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
The 5.0mm Crimp Positioning Pins are designed for use in the 5.0mm LCP holes of Synthes plates. The 7.3mm Crimp Positioning Pins are designed for use in the 7.3mm locking holes of Synthes plates.
| 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
"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."
FORM FDA 3881 (7/17)
PSC Pablishing Services (301) 443-6740 EF
3
Image /page/3/Picture/0 description: The image shows the logo for DePuy Synthes. The logo consists of a geometric shape on the left and the text "DePuy Synthes" on the right. The geometric shape is a sphere made up of intersecting lines, and the text is in a sans-serif font. The logo is in a blue and gold color scheme.
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) K172975
Device Name
DePuy Synthes Variable Angle Positioning Pins - MR Conditional
Indications for Use (Describe)
The DePuy Synthes Variable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant.
The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws.
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."
FORM FDA 3881 (7/17)
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Image /page/4/Picture/0 description: The image contains the logo for DePuy Synthes. The logo consists of a circular symbol on the left and the text "DePuy Synthes" on the right. The circular symbol is made up of several curved lines that intersect to form a spherical shape. The text "DePuy Synthes" is written in a sans-serif font, with "DePuy" in a slightly larger font size than "Synthes".
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) K172975
Device Name
DePuy Synthes Wire Mount - MR Conditional
Indications for Use (Describe)
The DePuy Synthes Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
The Wire Mount is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. The Wire Mount (and cerclage wire) can be used with a variety of plates that include, but are not limited to the following. Dynamic Hip Screw (DHS) Plates, Dynamic Condylar Screw (DCS) Plates, Condylar Buttress Plates, Hook Plates, 4.5 mm Narrow and Broad Dynamic Compression Plates (DCP), 90° Child and Adolescent Osteotomy Plates, 110-130° Adult Osteotomy Plates, and 95° Condylar and 130° Angle Blade Plates (both including small stature plates).
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."
FORM FDA 3881 (7/17)
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Image /page/5/Picture/0 description: The image shows the logo for DePuy Synthes. The logo consists of a circular graphic to the left of the company name. The graphic is a tan color and appears to be a stylized representation of a sphere. The company name, "DePuy Synthes", is written in a dark blue font.
T
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- |
|---|
| Indications for Use |
|---|
| --------------------- |
| 510(k) Number (if known) | K172975 |
|---|---|
| Device Name | DePuy Synthes Cerclage Positioning Pin- MR Conditional |
| Indications for Use (Describe) |
|---|
| -------------------------------- |
The DePuy Synthes Cerclage Positioning Pins are intended for use with cerclage monofilament wire and multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
Cerclage Positioning Pins are designed for use with plates having locking compression or dynamic compression screw holes that accept a 3.5 mm or 4.5 mm bone screws. The Cerclage Positioning Pin (and cerclage wire or cable) can be used with a variety of Synthes plates.
| 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."
| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
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Image /page/6/Picture/1 description: The image features the logo of DePuy Synthes, a company specializing in medical devices and orthopedic solutions. The logo consists of two distinct elements: a stylized, abstract symbol on the left and the company name "DePuy Synthes" on the right. The symbol is rendered in a light brown or gold color, while the company name is displayed in a dark blue font.
510(K) Summary for K081205:
Date Prepared: June 20, 2018
1.1. Submitter
Primary Contact: Suchitra Basu, PhD, RAC Global Strategy Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5448 sbasu23@its.jnj.com
Alternate Contact: Elizabeth Jacobs Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@its.jnj.com
1.2. Device
Name of Device: DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional Classification Name(s): Bone Fixation Cerclage Common or Usual Name(s): crimp, pin, Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II; 888.3010 Product Code(s): JDQ
1.3. Predicate Device
Synthes 5.0mm/7.3mm (USA) Crimp Positioning Pins (K081205)
1.3.1 Reference Device
DePuy Synthes Trauma Orthopedic Implant Portfolio – MR Conditional (K160553)
1.4. Device Description
The DePuy Synthes 5.0 mm and 7.3 mm Crimp Positioning Pins are designed to fit into the screw holes of existing DePuy Synthes fixation plates for the purpose of providing a guide for Cerclage cable positioning as well as a crimping point for Cerclage cable tension fixation. The Crimp Positioning pins are available in versions composed of implant quality stainless steel and titanium.
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Image /page/7/Picture/0 description: The image contains the logo for DePuy Synthes. The logo consists of a circular graphic on the left and the text "DePuy Synthes" on the right. The circular graphic is made up of several curved lines that intersect to form a spherical shape. The text "DePuy Synthes" is written in a sans-serif font and is colored in dark blue.
1.5. Indications for Use
The DePuy Synthes 5.0 mm and 7.3 mm Crimp Positioning Pins are intended for use with multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
The 5.0 mm Crimp Positioning Pins are designed for use in the 5.0 mm locking or 4.5 mm LCP holes of Synthes plates. The 7.3 mm Crimp Positioning Pins are designed for use in the 7.3 mm locking holes of Synthes Plates.
1.6. Substantial Equivalence
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes 5.0 mm and 7.3 mm Crimp Positioning Pins. The intended use and technological characteristics of the devices remains unchanged.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 5.0 mm and 7.3 mm Crimp Positioning Pins in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.
8
Image /page/8/Picture/1 description: The image shows the logo for DePuy Synthes. The logo consists of a geometric shape on the left and the text "DePuy Synthes" on the right. The geometric shape is a sphere made up of several smaller shapes. The text is in a sans-serif font and is colored blue.
510(k) Summary for K162124:
Date Prepared: June 20, 2018
1.1. Submitter
Primary Contact: Suchitra Basu, PhD, RAC Global Strategy Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5448 sbasu23@its.jnj.com
Alternate Contact: Elizabeth Jacobs Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@its.jnj.com
1.2. Device
Name of Device: DePuy Synthes Variable Angle Positioning Pins – MR Conditional Classification Name(s): Cerclage, Fixation Common or Usual Name(s): pin, Smooth or thread metallic bone fixation fastener Regulatory Class: Class II; 888.3010 Product Code(s): JDQ
1.3. Predicate Device
Synthes Variable Angle Positioning Pins (K162124)
1.3.1 Reference Device
DePuy Synthes Trauma Orthopedic Implant Portfolio - MR Conditional (K160553)
1.4. Device Description
The VA 5.0 Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0mm variable angle bone screws. Positioning or cerclage pins are intended for use with cerclage monofilament wire or multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant.
1.5. Indications for Use
The DePuy Synthes Variable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant.
9
Image /page/9/Picture/1 description: The image shows the logo for DePuy Synthes. The logo consists of a geometric shape on the left and the text "DePuy Synthes" on the right. The geometric shape is a sphere made up of intersecting lines, and the text is in a sans-serif font. The logo is simple and modern, and it is likely used to represent the company's brand.
The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws.
1.6. Substantial Equivalence
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Variable Angle Positioning Pins. The intended use and technological characteristics of the devices remains unchanged.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Variable Angle Positioning Pins in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.
10
Image /page/10/Picture/1 description: The image shows the logo for DePuy Synthes. The logo consists of a geometric shape on the left and the text "DePuy Synthes" on the right. The geometric shape is a sphere made up of several smaller shapes. The text is in a sans-serif font and is colored blue.
510(k) Summary for K953777:
Date Prepared: June 20, 2018
1.1. Submitter
Primary Contact:
Suchitra Basu, PhD, RAC Global Strategy Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5448 sbasu23@its.jnj.com
Alternate Contact:
Elizabeth Jacobs Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@its.jnj.com
1.2. Device
Name of Device: DePuy Synthes Wire Mount – MR Conditional Classification Name(s): Cerclage, Fixation Common or Usual Name(s): Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II; 888.3010 Product Code(s): JDQ
1.3. Predicate Device Synthes Wire Mount (K953777)
1.3.1 Reference Device
DePuy Synthes Trauma Orthopedic Implant Portfolio – MR Conditional (K160553)
1.4. Device Description
The Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates when use of screws is contraindicated, as in the presence of intramedullary implants. The design is a "T" post with a hole perpendicular to the post axis, and a small triangular ridge on the bottom. Placing the post through the dynamic compression screw hole, inserting from the bone side of the plate, creates a stable structure for cerclage wire fixation. The cerclage wire is passed around the bone, through the wire mount hole above the outer surface of the plate, and then twisted with the opposite wire end.
1.5. Indications for Use
The DePuy Synthes Wire Mount is intended for use with cerclage wire to augment fracture
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stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
The Wire Mount is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. The Wire Mount (and cerclage wire) can be used with a variety of plates that include, but are not limited to the following: Dynamic Hip Screw (DHS) Plates, Dynamic Condylar Screw (DCS) Plates, Condylar Buttress Plates, Cobra Head Plates, 4.5 mm Narrow and Broad Dynamic Compression Plates (DCP), 90° Child and Adolescent Osteotomy Plates, 110-130° Adult Osteotomy Plates, and 95° Condylar and 130° Angle Blade Plates (both including small stature plates).
1.6. Substantial Equivalence
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Wire Mount. The intended use and technological characteristics of the devices remain unchanged.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Wire Mount construct in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.
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510(k) Summary for K992891:
Date Prepared: June 20, 2018
1.1. Submitter
Primary Contact: Suchitra Basu, PhD, RAC Global Strategy Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5448 sbasu23@its.jnj.com
Alternate Contact: Elizabeth Jacobs Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@its.jnj.com
1.2. Device
Name of Device: DePuy Synthes Cerclage Positioning Pin- MR Conditional Classification Name(s): Cerclage, Fixation Common or Usual Name(s): Smooth or thread metallic bone fixation fastener Regulatory Class: Class II; 888.3010 Product Code(s): JDQ
1.3. Predicate Device
Synthes Cerclage Positioning Pin (K992891)
1.3.1 Reference Device
DePuy Synthes Trauma Orthopedic Implant Portfolio – MR Conditional (K160553)
1.4. Device Description
The design of the cerclage positioning pin is an oval body with a hole running perpendicular to the long axis (for use in compression holes), and has a stud protruding from the bottom. By placing the post through the top of the dynamic compression screw hole into a pre-drilled hole in cortical bone a stable structure is created for cerclage wire or cable fixation. The wire or cable is passed around the bone, through the Cerclage Positioning Pin hole above the outer plate surface, and then the wire is twisted or cable is crimped for final securement.
1.5. Indications for Use
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The DePuy Synthes Cerclage Positioning Pins are intended for use with cerclage monofilament wire and multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
Cerclage Positioning Pins are designed for use with plates having locking compression or dynamic compression screw holes that accept a 3.5 mm or 4.5 mm bone screw. The Cerclage Positioning Pin (and cerclage wire or cable) can be used with a variety of Synthes plates.
1.6. Substantial Equivalence
The purpose of this submission is to add MR Conditional information to the device labeling for the Synthes Cerclage Positioning Pin. The intended use and technological characteristics of the devices remains unchanged.
Non-clinical testing is provided to support the conditional safety of the Synthes Cerclage Positioning Pin construct in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.