(240 days)
No
The summary describes a mechanical orthopedic implant system and does not mention any AI or ML components.
No.
This device is a surgical implant designed to provide stable fixation for bone fractures, which is a supportive and mechanical function rather than a therapeutic one (e.g., delivering medication, stimulating healing directly, or modulating a physiological process).
No
Explanation: The device is a surgical implant (plate and screw system) used to stabilize fractures, not to diagnose a medical condition.
No
The device description explicitly states it consists of "anatomically-contoured, stainless steel and titanium plates and screws" and "system-specific instrumentation," indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the surgical fixation of bone fractures (distal femur fractures). This is a therapeutic and structural function, not a diagnostic one performed on samples taken from the body.
- Device Description: The device is described as plates, screws, and pins made of stainless steel and titanium, designed for bone fixation. This aligns with surgical implants, not diagnostic reagents or instruments.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Mentioning laboratory use or procedures
The device is a surgical implant used to stabilize bone fractures.
N/A
Intended Use / Indications for Use
The Synthes 4.5mm VA-LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supracondylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
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.
Product codes (comma separated list FDA assigned to the subject device)
JDP, HWC, JDQ, HRS
Device Description
The Synthes 4.5mm VA-LCP Curved Condylar Plate System consists of anatomically-contoured, stainless steel and titanium plates and screws featuring variable angle locking and combi-holes designed to provide stable fixation of the distal femur and system-specific instrumentation. The current 510(k) introduces OPTILINK™ Technology stainless steel screws, positioning pins for cerclage cable, and system-specific instrumentation as a line extension to the currently cleared Synthes 4.5mm VA-LCP Curved Condylar Plate System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femur and long bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Information presented supports substantial equivalence of the Synthes 4.5mm VA-LCP Curved Condylar Plate System Line extension parts and variable angle positioning pins compared to and compatible to the predicate Synthes 4.5mm VA-LCP Curved Condylar Plate System. The subject OPTILINK™ screws and Variable Angle Positioning Pins have the same indications for use, are similar in design, material, and fundamental technology as the predicates. The mechanical performance of the subject OPTILINK™ screws have been evaluated via Dynamic Fatigue Construct testing, Connection Strength testing, Torque-through and screw recess torsion tests, ASTM-543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws testing, which evaluated Torsional Properties, Insertion/Removal Torque, and Pull-out Strength. The devices also meet the specified endotoxin requirement of 20EU/device using the LAL test method.
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 4.5mm VA LCP Curved Condylar Plate System (K110354), 3.5 mm VA Locking Positioning Pin (K120689)
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.
Synthes 4.5 mm LCP Plate (K041911), Synthes 4.5 mm Broad LCP Plate (K000682), Synthes Cortical Screws (K112583), LCP Condylar Plate (K000066)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 29, 2017
DePuy Synthes Christopher J. Medberry, PhD, RAC Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K162124 Trade/Device Name: Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDP, HWC, JDQ, HRS Dated: March 1, 2017 Received: March 2, 2017
Dear Dr. Medberry:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K162124 |
| Device Name | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension |
| Indications for Use (Describe) | The Synthes 4.5mm VA LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions. |
| 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 (8/14)
PSC Publishing Services (301) 443-6740
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K162124 |
| Device Name | Variable Angle Positioning Pins |
| 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. | |
*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 (8/14)
PSC Polishing Services (901) 443-6740
4
- Date Prepared: March 28, 2017
- DePuy Synthes Sponsor:
- Primary Contact: Christopher J. Medberry. PhD. RAC Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, PA 19380 (610) 719-6806 Email: cmedberr@its.jnj.com
- Secondary Contact: Stacey Bonnell, MBA, RAC Associate Director Regulatory Affairs 1301 Goshen Parkway West Chester, PA 19380 (610) 719-5895 Email: sbonnell@its.jnj.com
Bundled Submission/Device Names:
-
- Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension
-
- Variable Angle Positioning Pins
- Requlation: Screws: §888.3030; Condylar Plate Fixation Implant - Single/multiple component metallic bone fixation appliances and accessories §888.3040; Screw, Fixation, Bone - Smooth or threaded metallic bone fixation fastener. Positioning Pins: §888.3010; Cerclage, Fixation - Bone fixation cerclage. System-specific Instruments: §888.3030; Condylar Plate Fixation Implant - Single/multiple component metallic bone fixation appliances and accessories; Classification/ Product Code: Screws: Class II / JDP, HWC Positioning Pins: Class II /JDQ System-specific Instruments: Class II / JDP, HRS, HWC Synthes 4.5mm VA LCP Curved Condylar Plate System (K110354) Predicate Devices: 3.5 mm VA Locking Positioning Pin (K120689) Reference Devices: Synthes 4.5 mm LCP Plate (K041911) Synthes 4.5 mm Broad LCP Plate (K000682) Synthes Cortical Screws (K112583) LCP Condylar Plate (K000066) Device Description: The Synthes 4.5mm VA-LCP Curved Condylar Plate System consists of anatomically-contoured, stainless steel and titanium plates and screws featuring variable angle locking and combi-holes designed to provide stable fixation of the distal femur and system-specific instrumentation. The current 510(k) introduces OPTILINK™ Technology stainless steel
5
screws, positioning pins for cerclage cable, and system-specific instrumentation as a line extension to the currently cleared Synthes 4.5mm VA-LCP Curved Condylar Plate System.
Intended Use/ Indications for Use:
Bundled Device #1 IFU: Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension The Synthes 4.5mm VA-LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supracondylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions. Bundled Device #2 IFU: Variable Angle Positioning Pins 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. Non-clinical Information presented supports substantial equivalence of the Synthes Performance Data: 4.5mm VA-LCP Curved Condylar Plate System Line extension parts and variable angle positioning pins compared to and compatible to the predicate Synthes 4.5mm VA-LCP Curved Condylar Plate System. The subject OPTILINK™ screws and Variable Angle Positioning Pins have the same indications for use, are similar in design, material, and fundamental technology as the predicates. The mechanical performance of the subject OPTILINK™ screws have been evaluated via Dynamic Fatigue Construct testing, Connection Strength testing, Torque-through and screw recess torsion tests, ASTM-543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws testing, which evaluated Torsional Properties, Insertion/Removal Torque, and Pull-out Strength. The devices also meet the specified endotoxin requirement of 20EU/device using the LAL test method.
Clinical Performance Data:
Clinical data was not needed to demonstrate the safety and effectiveness of the proposed devices.
Material Characterization
The proposed OPTILINK™ technology screws have been evaluated to Evidence: determine the metallurgical corrosion behavior via anodic polarization,
6
galvanic and fretting corrosion assessments using both stainless steel and titanium plates. Conclusions drawn from these evaluations demonstrate substantial equivalence to the predicate device.
- Conclusion: The subject devices demonstrate substantial equivalence to the predicate devices.