(265 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and equivalence of a bone screw, with no mention of AI or ML.
Yes
The device is described as titanium alloy screws intended for the "fixation of fractures, fusions, osteotomies, nonunions, and malunions" of bones, which clearly indicates a therapeutic purpose by treating or alleviating a medical condition.
No
The device is described as an implantable screw used for skeletal fixation, not for diagnosis.
No
The device description explicitly states the device is comprised of a screw and post made of a titanium alloy, indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (screws) intended for the fixation of bones during surgical procedures. It is used in vivo (within the body) to provide structural support and stability to fractured or damaged bones.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's health status. Its function is purely mechanical and therapeutic.
Therefore, based on the provided description, the DePuy Synthes 2.0 mm Quick Insertion Screws are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Synthes 2.0 mm Quick Insertion Screws are intended for fixation of fractures, fusions, osteotomies, nonunions, and malunions of the bones of the forefoot, midfoot, and hand in patients 2 years of age and older 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 2.0 mm Quick Insertion Screws (Ql Screws) are twist-off style screws comprised of a screw and post which are intended to separate at a predefined location (the breakpoint) as the screw is implanted into bone. The screws are offered with an external thread diameter of 2.0 mm and in lengths ranging from 11 mm to accommodate varying patient anatomy and fracture patterns in the foot and hand. The screws are made of a titanium alloy (Ti-6Al-7Nb) in accordance with ASTM F1295.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forefoot, midfoot, and hand
Indicated Patient Age Range
2 years of age and older
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
Non-clinical performance data is provided in this submission to support substantial equivalence of the subject device to the primary predicate.
- Comparison of the ratio of Peak Insertion Torque (ASTM F543 A2) to Torsional Yield Strength (ASTM F543 A1) for the subject and primary predicate device supports that the subject device's is equivalent to the primary predicate.
- Comparative testing of the Axial Pullout (ASTM F543 A3) of the subject and primary predicate device supports that the subject device is equivalent to the primary predicate.
- Comparative testing of the Bending Strength (based on ASTM F2193-14 A4) of the subject and primary predicate device supports that the subject device is equivalent to the primary predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
November 21, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Synthes USA Products, LLC Rebecca G. Reiter Regulatory Project leader 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K180541
Trade/Device Name: DePuy Synthes 2.0 mm Quick Insertion Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 18, 2018 Received: October 19, 2018
Dear Rebecca G. Reiter:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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.
Shumaya Ali -S-1
- For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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) K180541
Device Name
DePuy Synthes 2.0 mm Quick Insertion Screws
Indications for Use (Describe)
The DePuy Synthes 2.0 mm Quick Insertion Screws are intended for fixation of fractures, fusions, osteotomies, nonunions, and malunions of the bones of the forefoot, midfoot, and hand in patients 2 years of age and older 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) |
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FORM FDA 3881 (8/14)
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510(k) Summary
Date Prepared: February 27, 2018
Submitter 1.
Primary Contact: Rebecca G. Reiter Regulatory Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-1268 rreiter@its.jnj.com
Alternate Contact: Susan Lewandowski Associate Director, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5852 slewand2@its.jnj.com
2. Device
Name of Device: DePuy Synthes 2.0 mm Quick Insertion Screws Common or Usual Name(s): Bone, Fixation, Screw Classification Name(s): Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II - 888.3040 Product Code: HWC
ന് Primary predicate devices
Primary Predicate: Zimmer Biomet FRS Twist-off Screw (K142658) Additional Predicate: Synthes 2.0 mm Cortical Screws (K112583)
4. Indications for Use
The DePuy Synthes 2.0 mm Quick Insertion Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the bones of the forefoot, midfoot, and hand in patients 2 years of age and older in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
5. Device Description
The DePuy Synthes 2.0 mm Quick Insertion Screws (Ql Screws) are twist-off style screws comprised of a screw and post which are intended to separate at a predefined location (the breakpoint) as the screw is implanted into bone. The screws are offered with an external thread diameter of 2.0 mm and in lengths ranging from 11 mm to accommodate varying patient anatomy and fracture patterns in the foot and hand. The screws are made of a titanium alloy (Ti-6Al-7Nb) in accordance with ASTM F1295.
4
Comparison to Primary predicate devices 6.
Intended Use 6.1.
Both the subject screws and the primary predicate, Zimmer Biomet FRS Twist-off Screw (K142658), are indicated for fixation of bones in the forefoot, midfoot, and hand in adult patients. The subject screws are additionally proposed for use in pediatric patients in alignment with the pediatric indications of Synthes 2.0 mm Cortical Screw (K112583). The proposed indications of the subject device do not constitute a new intended use not already addressed by the predicates.
6.2. Technological Specifications
Justifications and non-clinical performance data provided in this submission demonstrate that the subject device is substantially equivalent to the predicate despite differences in technological specifications. The following specifications were compared between the subject and primary predicate devices:
- . Screw Tip
- Screw Thread and Shaft
- . Screw Shaft to Head Transition
- Post
- Material
- Principles of Operation ●
- Sterilization
7. Non-clinical performance data
Non-clinical performance data is provided in this submission to support substantial equivalence of the subject device to the primary predicate.
- . Comparison of the ratio of Peak Insertion Torque (ASTM F543 A2) to Torsional Yield Strength (ASTM F543 A1) for the subject and primary predicate device supports that the subject device's is equivalent to the primary predicate.
- . Comparative testing of the Axial Pullout (ASTM F543 A3) of the subject and primary predicate device supports that the subject device is equivalent to the primary predicate.
- . Comparative testing of the Bending Strength (based on ASTM F2193-14 A4) of the subject and primary predicate device supports that the subject device is equivalent to the primary predicate.
8. Clinical performance data
No clinical performance data is provided in this submission.
9. Substantial Equivalence
A comparison of the subject device with the primary predicate devices is provided in this submission.
5
Both the subject screws and the primary predicate, Zimmer Biomet FRS Twist-off Screw (K142658), are indicated for fixation of bones in the forefoot, and hand in adult patients. The subject screws are additionally proposed for use in pediatric patients in alignment with the pediatric indications of Synthes 2.0 mm Cortical Screw (K112583). The proposed indications of the subject device do not constitute a new intended use not already addressed by the predicates.
The subject device and predicate devices are very similar in design, and, as a result, share many of the same technological specifications and similar principles of operation. Evaluation of the technological differences demonstrates the subject device is as safe and effective as the predicates.
The subject and predicate devices share the same intended use, and differences in technological characteristics do not raise new questions of safety and efficacy. The subject DePuy Synthes 2.0 mm Quick Insertion Screw is substantially equivalent to the predicates.