(248 days)
No
The summary describes metallic bone screws for fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "metallic bone screws" intended for "internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions," which directly aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No.
Explanation: The "Intended Use / Indications for Use" section clearly states that the DePuy Synthes screws are "intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions." These are all surgical interventions, not diagnostic procedures. The device description also refers to them as "internal bone fixation" devices. There is no mention of the device being used to identify or characterize a disease or condition.
No
The device description clearly states that the devices are metallic bone screws, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these screws are for the fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones. This is a surgical intervention for treating physical conditions.
- Device Description: The device description details metallic bone screws used for internal bone fixation. This is a physical implant.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples or diagnostic purposes.
The device is a surgical implant used for orthopedic procedures, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The DePuy Synthes 2.4 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 4.0 mm Cortex Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, fibula, and the bones of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 4.5 mm Cortex Screws are intended for fixation of fractures, fusion, osteotomies, non-unions, and malunions of various long bones, such as the humerus, femur and tibia; the pelvis, and the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 4.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bone fragments; and the bones of the hand and foot, in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 6.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for femoral neck fractures; slipped capital femoral epiphysis; an adjunct to DHS in basilar neck fractures; ankle arthrodesis; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
The DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for slipped capital femoral epiphysis; ankle arthrodesis; and subtalar arthrodesis.
The DePuy Synthes 1.5 mm Headless Compression Screws are intended for fixation of intra-articular fractures, avulsions, non-unions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 2.4 mm Headless Compression Screws are intended for fixation of fractures, non-unions, and malunions of small bones and small bone arthrodesis in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular fractures, non-unions, malunions, and osteotomies of small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of various bone fragments including bones of the foot, humerus, femur and tibia in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
Product codes
HWC
Device Description
The DePuy Synthes Cortex, Cannulated, and Headless Compression Screws are metallic bone screws manufactured from Stainless Steel (ASTM F138), Commercially Pure Titanium (ASTM F67), and/or Titanium Alloy (ASTM F1295). The screws are available in multiple lengths and diameters, and are intended to be used as stand-alone bone screws for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.
The DePuy Synthes Cannulated and Headless Compression screws are cannulated for use with guidewires for precise placement in bone with the exception of the 1.5 mm Headless Compression Screw, which is a solid screw and therefore does not allow for instrumentation with a guide wire. The Headless Compression Screws feature threaded heads that allow for purchase in the near cortex of bone during and after implantation, potentially reducing complications associated with countersinking of traditional cortex or cannulated screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones, clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, fibula, bones of the foot and hand, long bones and long bone fragments, sacrum, SI joint, ankle
Indicated Patient Age Range
Adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
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)
Bench: There is no bench testing included in this submission.
Animal: There is no animal data included in this submission.
Clinical: This submission contains published clinical literature to support the safety and efficacy of the modifications to the Indications for Use of the DePuy Synthes Cortex, Cannulated, and Headless Compression Screws. The positive clinical outcomes from the clinical literature and comparison to predicate devices provided in the submission demonstrate that the modifications to the Indications for Use supports substantial equivalence.
Non-Clinical: Bacterial Endotoxin Testing was conducted and met the specified endotoxin limits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K112583, K012945, K963192, K963172, K021932, K962011, K090949, K050636, K080943
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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 two main elements: a circular text element and a stylized graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The graphic element features a stylized representation of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2017
Synthes USA Products, LLC Nina Rudolph Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K161616
Trade/Device Name: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuv Synthes 3.0 mm Headless Compression Screws. DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: January 25, 2017 Received: January 27, 2017
Dear Ms. Rudolph:
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.
1
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 the quality systems (QS) 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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161616
Device Name
DePuy Synthes 2.4 mm Cannulated Screws
Indications for Use (Describe)
The DePuy Synthes 2.4 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
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
3
Indications for Use
510(k) Number (if known) K161616
Device Name
DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws
Indications for Use (Describe)
The DePuy Synthes 4.0 mm Cortex Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, fibula, and the bones of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 4.5 mm Cortex Screws are intended for fixation of fractures, fusion, osteotomies, non-unions, and malunions of various long bones, such as the humerus, femur and tibia; the pelvis, and the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
Type of Use (Select one or both, as applicable)
| Compounding Use (Part 21 CFR 201.2 and D) |
|---|
| Over-The-Counter Use (21 CFR 201.S) |
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 Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K161616
Device Name
DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws
Indications for Use (Describe)
The DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
| 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
5
Indications for Use
510(k) Number (if known)
K161616
Device Name DePuy Synthes 4.5 mm Cannulated Screws
Indications for Use (Describe)
The DePuy Synthes 4.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments; and the bones of the hand and foot, in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
| 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 Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
6
Indications for Use
510(k) Number (if known)
Device Name DePuy Synthes 6.5 mm Cannulated Screws
Indications for Use (Describe)
The DePuy Synthes 6.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for femoral neck fractures; slipped capital femoral epiphysis; an adjunct to DHS in basilar neck fractures; ankle arthrodesis; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
| 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."
7
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws
Indications for Use (Describe)
The DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for slipped capital femoral epiphysis; ankle arthrodesis; and subtalar arthrodesis.
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
8
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
DePuy Synthes 1.5 mm Headless Compression Screws
Indications for Use (Describe)
The DePuy Synthes 1.5 mm Headless Compression Screws are intended for fixation of intra-articular fractures, avulsions, non-unions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
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
9
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
DePuy Synthes 2.4 mm Headless Compression Screws
Indications for Use (Describe)
The DePuy Synthes 2.4 mm Headless Compression Screws are intended for fixation of fractures, non-unions, and malunions of small bones and small bone arthrodesis in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
| 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
10
Indications for Use
510(k) Number (if known)
Device Name
DePuy Synthes 3.0 mm Headless Compression Screws
Indications for Use (Describe)
The DePuy Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular fractures, non-unions, malunions, and osteotomies of small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
| 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
11
Indications for Use
510(k) Number (if known)
K161616
Device Name
DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screws
Indications for Use (Describe)
The DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of various bone fragments including bones of the foot, humerus, femur and tibia in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
| 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
12
Image /page/12/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A registered trademark symbol is located to the right of the word.
5. 510(k) Summary
| Date Prepared: | February 14, 2017 |
|---|---|
| Submitter: | Synthes USA Products, LLC |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| United States of America | |
| Contact: | Nina Rudolph |
| Regulatory Affairs Specialist | |
| DePuy Synthes | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| Phone: (610) 719-6935 | |
| Nrudolph@its.jnj.com | |
| Device Name: | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, |
| DePuy Synthes 2.4 mm Cannulated Screws, | |
| DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, | |
| DePuy Synthes 4.5 mm Cannulated Screws, | |
| DePuy Synthes 6.5 mm Cannulated Screws, | |
| DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, | |
| DePuy Synthes 1.5 mm Headless Compression Screws, | |
| DePuy Synthes 2.4 mm Headless Compression Screws, | |
| DePuy Synthes 3.0 mm Headless Compression Screws, and | |
| DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screws | |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Regulatory Class: | II |
| Product Code: | HWC (Screw, Fixation, Bone) |
| 21 CFR §888.3040 |
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Image /page/13/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. A horizontal line runs beneath the word, emphasizing the brand name.
5.1. Predicate Devices
Primary Predicate Devices:
Table 2 details the subject devices and the associated primary predicate.
Table 1: Primary Predicate Device Table
| Subject Device | Primary Predicate |
|---|---|
| DePuy Synthes 4.0 mm and 4.5 mm | |
| Cortex Screws | K112583 – Synthes Cortex Screws 4.0 mm |
| and 4.5 mm Cortex Screws | |
| DePuy Synthes 2.4 mm Cannulated | |
| Screws | K012945 – Synthes 2.4 mm Cannulated |
| Screw | |
| DePuy Synthes 3.5 mm and 4.0 mm | |
| Cannulated Screws | K963192 – Synthes Sterile 3.5 mm and 4.0 |
| mm Cannulated Screws | |
| DePuy Synthes 4.5 mm Cannulated Screw | K963172 – Synthes Sterile 4.5 mm |
| Cannulated Screw | |
| DePuy Synthes 6.5 mm Cannulated Screw | K021932 – Synthes 6.5 mm Cannulated |
| Screw | |
| DePuy Synthes 7.0 mm and 7.3 mm | |
| Cannulated Screws | K962011 – Synthes 7.0 mm and 7.3 mm |
| Cannulated Screws | |
| DePuy Synthes 1.5 mm Headless | |
| Compression Screws | K090949 – Synthes 1.5 mm Headless |
| Compression Screws | |
| DePuy Synthes 2.4 mm Headless | |
| Compression Screws | K012945 – Synthes 2.4 mm Cannulated |
| Screw | |
| DePuy Synthes 3.0 mm Headless | |
| Compression Screws | K050636 – Synthes 3.0 mm Headless |
| Compression Screws | |
| DePuy Synthes 4.5 mm and 6.5 mm | |
| Headless Compression Screws | K080943 – Synthes 4.5 mm and 6.5 mm |
| Headless Compression Screws |
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Image /page/14/Picture/1 description: The image shows the Synthes logo. The logo consists of a circular icon on the left and the word "SYNTHES" in bold, sans-serif font to the right. There is a horizontal line below the word "SYNTHES".
Additional Predicate Device:
Comparison to an additional predicate, Synthes 2.4 mm Cannulated Compression Screw (K021556), is used in support of the design changes disclosed in this submission to Synthes 2.4 mm Cannulated Screw (K012945). The design changes resulted in new part numbers referred to as the DePuy Synthes 2.4 mm Headless Compression Screws.
Table 2: Additional Predicate Device Table
| Subject Device | Additional Predicate |
|---|---|
| DePuy Synthes 2.4 mm Headless | K021556 – Synthes 2.4 mm Cannulated |
| Compression Screws | Compression Screw |
5.2. Device Description
The DePuy Synthes Cortex, Cannulated, and Headless Compression Screws are metallic bone screws manufactured from Stainless Steel (ASTM F138), Commercially Pure Titanium (ASTM F67), and/or Titanium Alloy (ASTM F1295). The screws are available in multiple lengths and diameters, and are intended to be used as stand-alone bone screws for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.
The DePuy Synthes Cannulated and Headless Compression screws are cannulated for use with guidewires for precise placement in bone with the exception of the 1.5 mm Headless Compression Screw, which is a solid screw and therefore does not allow for instrumentation with a guide wire. The Headless Compression Screws feature threaded heads that allow for purchase in the near cortex of bone during and after implantation, potentially reducing complications associated with countersinking of traditional cortex or cannulated screws.
5.3. Indications for Use
The DePuy Synthes 4.0 mm Cortex Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, fibula, and the bones of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 4.5 mm Cortex Screws are intended for fixation of fractures, fusion, osteotomies, non-unions, and malunions of various long bones, such as the humerus, femur and tibia; the pelvis, and the bones of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
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Image /page/15/Picture/1 description: The image shows the Synthes logo. The logo consists of a circular icon on the left and the word "SYNTHES" in bold, sans-serif font on the right. There is a horizontal line below the logo.
The DePuy Synthes 2.4 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones and small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 4.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bone fragments; and the bones of the hand and foot, in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 6.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for femoral neck fractures; slipped capital femoral epiphysis; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
The DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for slipped capital femoral epiphysis; ankle arthrodesis; and subtalar arthrodesis.
The DePuy Synthes 1.5 mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures, avulsions, malunions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 2.4 mm Headless Compression Screws are intended for fixation of fractures, osteotomies, non-unions, and malunions of small bone arthrodesis in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
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The DePuy Synthes 3.0 mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures, non-unions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of various bones and bone fragments including bones of the foot, humerus, femur and tibia in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
Discussion:
Both the subject devices and the primary predicate devices share intended use; comparison of the indications of the subject and predicate device in addition to positive results from the provided clinical literature demonstrate that the proposed changes to the Indications for Use of the subject devices supports substantial equivalence.
Comparison of Technological Characteristics with the Predicate Device 5.4.
Cortex Screws:
Technological characteristics of the cortex screws include features such as thread form, tip design, and recess type, dimensions such as length and diameter, material of construction, and sterility. A comparison table of the subject devices and the predicate devices technological characteristics are provided within the submission.
There have been no design changes to the DePuy Synthes Cortex Screws 4.0 mm and 4.5 mm Cortex Screws since the previous clearance (K112583). Therefore, there are no differences in technological characteristics in comparison to the predicate device (K112583) that raise new questions of safety and efficacy.
Cannulated Screws:
Technological characteristics of the cannulated screws include features such as thread form, tip design, and recess type, dimensions such as length and diameter, material of construction, and sterility. A comparison table of the subject devices and the predicate devices technological characteristics are provided within the submission.
Design changes resulting in additional part numbers to Synthes 2.4 mm Cannulated Screw (K012945), Synthes Sterile 3.5 mm and 4.0 mm Cannulated Screws (K963192), Synthes Sterile 4.5 mm Cannulated Screw (K963172), and Synthes 7.0 mm and 7.3 mm Cannulated Screws
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Image /page/17/Picture/1 description: The image shows the Synthes logo in black and white. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold letters on the right. There is a horizontal line below the word "SYNTHES".
(K962011) were assessed per FDA's Guidance Document entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" issued January 10, 1997 and resulted in internal documentation. DePuy Synthes also offers Synthes 3.5 mm and 4.0 mm Cannulated Screws (K963192), Synthes 4.5 mm Cannulated Screw (K963172), and Synthes 7.0 mm and 7.3 mm Cannulated Screws (K962011) non-sterile, whereas the previous submission of these devices was for sterile devices only. Per FDA's Guidance Document entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" issued January 10, 1997 there is no change in the SAL of the devices since their previous clearance, and therefore, there are no new issues of safety and efficacy. There have been no design changes to the Synthes 6.5 mm Cannulated Screws previously cleared in K021932. Therefore, there are no differences in technological characteristics of the subject devices in comparison to the predicate devices that raise new questions of safety and efficacy.
Headless Compression Screws:
Technological characteristics of the Headless Compression Screws include features such as thread form, tip design, and recess type, dimensions such as length and diameter, material of construction, and sterility. A comparison table of the subject devices and the predicate devices technological characteristics are provided within the submission.
Design changes and additional part numbers to Synthes 2.4 mm Cannulated Screw (K012945) include 2.4 mm Headless Compression Screws. The changes were assessed per FDA's Guidance Document entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" issued January 10, 1997 and resulted in documentation. Additionally, there have been no design changes to the Headless Compression Screws previously cleared in K090949, K050636, and K080943. Therefore, there are no differences in technological characteristics of the subject devices in comparison to the predicate devices that raise new questions of safety and efficacy.
5.5. Performance Data
Bench:
There is no bench testing included in this submission.
Animal:
There is no animal data included in this submission.
Clinical:
This submission contains published clinical literature to support the safety and efficacy of the modifications to the Indications for Use of the DePuy Synthes Cortex, Cannulated, and Headless Compression Screws. The positive clinical outcomes from the clinical literature and comparison
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Image /page/18/Picture/1 description: The image shows the Synthes logo. The logo consists of a circular icon on the left and the word "SYNTHES" in bold, sans-serif font on the right. A registered trademark symbol is located to the upper right of the "S" in "SYNTHES". A horizontal line is located underneath the logo.
to predicate devices provided in the submission demonstrate that the modifications to the Indications for Use supports substantial equivalence.
Non-Clinical:
Bacterial Endotoxin Testing was conducted and met the specified endotoxin limits.
Conclusions
The intent of this submission is to modify the indications for use for the DePuy Synthes Cortex, Cannulated, and Headless Compression Screws and to disclose design changes and additional part numbers to the subject devices since their previous clearance.
- 0 Published clinical literature supports that the modifications to the Indications for Use for the subject devices.
- Design changes were assessed per FDA's Guidance Document entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" issued January 10, 1997 and resulted in internal documentation.
- 0 There have been no design changes to any of the other subject devices since their previous clearance, and as a result, there are no differences in technological characteristics in comparison to the predicate devices for those devices that raise different questions of safety and efficacy.
The proposed Cortex, Cannulated, and Headless Compression Screws have similar Indications for Use, share the same design characteristics, incorporate the same fundamental product technology, and are composed of the same materials when compared to the previous clearance of the devices which serve as the predicate devices. It is concluded that the information included in this submission supports substantial equivalence.