(62 days)
Not Found
No
The device description focuses on mechanical components (plates and screws) for fracture fixation and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
No
This device is for fracture fixation and reconstructive procedures of the hand and other small bones, which is a structural repair rather than a therapeutic treatment in the conventional sense of treating a disease or disorder.
No
This device is for fracture fixation and reconstruction of bones, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states it consists of "stainless steel and titanium plates and screws" and mentions "general instruments, and device specific instruments," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of fractures and other bone issues within the body (in vivo). IVDs are used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details plates and screws made of stainless steel and titanium, which are surgical implants used for internal fixation. This is consistent with a surgical device, not an IVD.
- No mention of biological samples: There is no mention of the device interacting with or analyzing biological samples like blood, urine, tissue, etc., which is a hallmark of IVDs.
- Performance Studies: The performance studies described focus on the mechanical strength and fatigue of the plates and screws, which are relevant to the structural integrity of a surgical implant. IVD performance studies would typically involve metrics like sensitivity, specificity, accuracy in detecting analytes, etc.
In summary, the DePuy Synthes Variable Angle Locking Hand System is a surgical device intended for internal fixation of bones, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone.
System indications include the following:
o Open reduction and internal fixation of fractures, mal-unions, and non-unions
o Following excision of benign bone tumors
- o Replantations and reconstructions
- o Arthrodeses of joints involving small bones
- o Osteotomies, including deformity correction such as rotation, lengthening, shortening
o Pathological fractures, including impending pathologic fractures
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) consists of stainless steel and titanium plates and screws that offer screw-to-plate locking designed for various fracture modes of the hand. The plates and screws contained in the DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) are offered in a range of configurations to accommodate patient anatomy and surgical need. The subject system contains two plate and screw sizes, 1.3 mm and 2.0 mm, general instruments, and device specific instruments. The 1.3 mm plates in this submission are designed to accept new 1.3 mm cortex and locking screws. The 2.0 mm plates are designed to accept existing 2.0 mm cortex screws, 2.0 mm locking screws, and new 2.0 mm Variable Angle (VA) locking screws. The new 2.0 mm VA locking plates and screws feature existing variable angle locking technology (K100776).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and other small bones and small bone fragments
Indicated Patient Age Range
adults and adolescents (12-21)
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)
Fatigue strength testing was completed for the plates included in the subject system, demonstrating equal or greater strength in comparison to representative predicate plates. Plates were setup for fatigue strength testing in a plate-screw construct configuration that was intended to target the weakest portion of the plate by aligning the simulated fracture gap with the plate's smallest cross sectional area. New 1.3 mm Cortex and Locking Screws and 2.0 mm VA Locking Screws were tested using methods detailed in ASTM F543-13 in order to demonstrate performance in accordance with the specifications of the standard or in cases where a benchmark specification was not available, comparison was made to representative predicate devices. Literature has been provided to support the revision in indications, most notably the addition of the adolescent population Lastly, technological characteristics of the DePuy Synthes Variable Angle System such as locking holes, limited contact profiles, variable and standard locking technology, anatomic contours, and size ranges are prominent throughout the representative predicate systems.
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.
K030310, K063049, K100776, K112583
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2015
Synthes (USA) Products, LLC Mr. Nicholas Fountoulakis Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K150099
Trade/Device Name: DePuy Synthes Variable Angle Locking Hand System (1.3mm and 2.0mm Plates and Screws) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: January 16, 2015 Received: January 20, 2015
Dear Mr. Fountoulakis:
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
1
Page 2 - Mr. Nicholas Fountoulakis
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good 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.
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" (21CFR 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 yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
DePuy Synthes Variable Angle Locking Hand System (1.3mm and 2.0mm Plates and Screws)
Indications for Use (Describe)
The DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone.
System indications include the following:
o Open reduction and internal fixation of fractures, mal-unions, and non-unions
o Following excision of benign bone tumors
- o Replantations and reconstructions
- o Arthrodeses of joints involving small bones
- o Osteotomies, including deformity correction such as rotation, lengthening, shortening
o Pathological fractures, including impending pathologic fractures
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
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."
3
510(k) Summary
Date Prepared: March 13, 2015
| Sponsor: | DePuy Synthes
Nicholas S. Fountoulakis
1301 Goshen Parkway
West Chester, PA 19380
Office: (610) 719-6553
Fax: (484) 356-9682 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary
Name: | DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates
and Screws) |
| Classification: | Class II, HRS, §888.3030 – Plate, Fixation, Bone
Class II, HWC, §888.3040 - Screw, Fixation, Bone |
| Primary
Predicate
Devices | K030310 – Synthes Stainless Steel Modular Hand System |
| Additional
Predicate
Devices | K063049 – Synthes (USA) Modular Mini Fragment LCP System
K100776 - Synthes 2.4 mm/2.7 mm Variable Angle LCP Forefoot/Midfoot System
K112583 - Synthes Cortical Screws |
| Device
Description: | The DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm
Plates and Screws) consists of stainless steel and titanium plates and screws that
offer screw-to-plate locking designed for various fracture modes of the hand. The
plates and screws contained in the DePuy Synthes Variable Angle Locking Hand
System (1.3 mm and 2.0 mm Plates and Screws) are offered in a range of
configurations to accommodate patient anatomy and surgical need. The subject
system contains two plate and screw sizes, 1.3 mm and 2.0 mm, general instruments,
and device specific instruments. The 1.3 mm plates in this submission are designed
to accept new 1.3 mm cortex and locking screws. The 2.0 mm plates are designed to
accept existing 2.0 mm cortex screws, 2.0 mm locking screws, and new 2.0 mm
Variable Angle (VA) locking screws. The new 2.0 mm VA locking plates and screws
feature existing variable angle locking technology (K100776). |
| Indications for
Use: | The DePuy Synthes Variable Angle Locking Hand System is intended for fracture
fixation of the hand and other small bones and small bone fragments, in adults and
adolescents (12-21) particularly in osteopenic bone.
System indications include the following:
Open reduction and internal fixation of fractures, mal-unions, and non-unions Following excision of benign bone tumors Replantations and reconstructions Arthrodeses of joints involving small bones Osteotomies, including deformity correction such as rotation, lengthening, shortening Pathological fractures, including impending pathologic fractures |
| Substantial
Equivalence: | The proposed DePuy Synthes Variable Angle (VA) Locking Hand System (1.3 mm
and 2.0 mm Plates and Screws) shares the same fundamental technological
characteristics and intended use as the predicate Synthes systems (K030310,
K112583, K063049, K100776). Fatigue strength testing was completed for the
plates included in the subject system, demonstrating equal or greater strength in
comparison to representative predicate plates. Plates were setup for fatigue strength
testing in a plate-screw construct configuration that was intended to target the
weakest portion of the plate by aligning the simulated fracture gap with the plate's
smallest cross sectional area. New 1.3 mm Cortex and Locking Screws and 2.0 mm
VA Locking Screws were tested using methods detailed in ASTM F543-13 in order
to demonstrate performance in accordance with the specifications of the standard or
in cases where a benchmark specification was not available, comparison was made to
representative predicate devices. Literature has been provided to support the revision
in indications, most notably the addition of the adolescent population Lastly,
technological characteristics of the DePuy Synthes Variable Angle System such as
locking holes, limited contact profiles, variable and standard locking technology,
anatomic contours, and size ranges are prominent throughout the representative
predicate systems. Based on the similarity of technical features across the predicate
device, results of the performance data, and literature discussions, the subject DePuy
Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and
Screws) is substantially equivalent to the predicate devices. |
4