(214 days)
Not Found
No
The device description and intended use are for bone screws, which are mechanical implants. There is no mention of software, algorithms, or any technology that would incorporate AI or ML. The submission focuses on updating labeling for existing hardware.
No
The device is a bone screw intended for surgical use in treating bone fractures and other related conditions, not for providing therapy.
No
The provided text explicitly states the device is a "bone screw" indicated for "treatment of bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment." These are all therapeutic applications, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The device description explicitly states it consists of "cannulated screws with diameters ranging from 2.5 mm to 4.0 mm" made from "anodized titanium alloy," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is a set of bone screws made of titanium, intended for surgical implantation to treat bone fractures, osteotomies, and other bone-related issues. It is used in the body, not to test samples from the body.
The information provided describes a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Stryker Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5 mm, 3.0 mm, and 4.0 mm bone screws are indicated for use in the treatment of bone fractures, osteochondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, hand surgery, orthopedic surgery, plastic surgery, and podiatric surgery. These devices are not intended for use in the spine.
The Stryker Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications:
- Scaphoid fractures
- Lunate fractures
- Capitate fractures
- Trapezial fractures
- Metacarpal fractures
- Metatarsal fractures
- Phalangeal fractures
- Radial head fractures
- Ulnar styloid fractures
- Small joint fusion
- Osteochondral fractures
- Humeral head fractures
- Glenoid fractures
- Carpometacarpal joint fractures
- Interphalangeal joint fractures
- Tarsal fusions
- Malleolar fractures
- Patellar fractures
- Metaphyseal fractures
- Interfragmentary radius fractures
- Interfragmentary ulnar fractures
- Small hand and wrist bone fractures
- Distal metatarsal osteotomies
- Forefoot interfragmentary fractures
- Midfoot interfragmentary fractures
Product codes
HWC
Device Description
The Mini Cannulated Titanium Headed and Headless Screw Set consists of cannulated screws with diameters ranging from 2.5 mm to 4.0 mm. The cannulated screws have a torx head design and are made from anodized titanium alloy. This submission seeks to update labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and interfragmentary indications including specific long bone indications (e.g., Scaphoid, Lunate, Capitate, Trapezial, Metacarpal, Metatarsal, Phalangeal, Radial head, Ulnar styloid, Humeral head, Glenoid, Carpometacarpal joint, Interphalangeal joint, Tarsal, Malleolar, Patellar)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hand surgery, orthopedic surgery, plastic surgery, and podiatric surgery.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: This submission does not require non-clinical testing.
Clinical Testing: This submission does not require clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 10, 2019
Stryker GmbH Sanja Jahr Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K183104
Trade/Device Name: Mini Cannulated Headed and Headless Screw Set Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastner Regulatory Class: Class II Product Code: HWC Dated: November 7, 2018 Received: November 8, 2018
Dear Sanja Jahr:
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. Although this letter refers to your product as a device, please be aware 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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 mediation-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,
for Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183104
Device Name
Mini Cannulated Titanium Headed and Headless Screw Set
Indications for Use (Describe)
The Stryker Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5 mm, 3.0 mm, and 4.0 mm bone screws are indicated for use in the treatment of bone fractures, osteochondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, hand surgery, orthopedic surgery, plastic surgery, and podiatric surgery. These devices are not intended for use in the spine.
The Stryker Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications:
- Scaphoid fractures
- Lunate fractures
- Capitate fractures
- Trapezial fractures
- Metacarpal fractures
- Metatarsal fractures
- Phalangeal fractures
- Radial head fractures
- Ulnar styloid fractures
- Small joint fusion
- Osteochondral fractures
- Humeral head fractures
- Glenoid fractures
- Carpometacarpal joint fractures
- Interphalangeal joint fractures
- Tarsal fusions
- Malleolar fractures
- Patellar fractures
- Metaphyseal fractures
- Interfragmentary radius fractures
- Interfragmentary ulnar fractures
- Small hand and wrist bone fractures
- Distal metatarsal osteotomies
- Forefoot interfragmentary fractures
- Midfoot interfragmentary fractures
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.
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510(k) Summary
| Proprietary Name: | Mini Cannulated Titanium Headed and Headless Screw Set |
|---|---|
| Common Name: | Bone Screw |
| Regulation Description: | Smooth or threaded metallic bone fixation fastener |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | HWC |
| Device Class: | Class II |
| Sponsor: | Stryker GMBH |
| Bohnackerweg 1 | |
| 2545 Selzach / Switzerland | |
| Contact Person: | Sanja Jahr |
| Senior Regulatory Affairs Specialist | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: 201-831-6797 | |
| Fax: 201-831-6020 | |
| Date Prepared: | November 7, 2018 |
| Primary Predicate: | Mini Cannulated Titanium Headed and Headless Screw Set |
| (K120493) |
Description
The Mini Cannulated Titanium Headed and Headless Screw Set consists of cannulated screws with diameters ranging from 2.5 mm to 4.0 mm. The cannulated screws have a torx head design and are made from anodized titanium alloy. This submission seeks to update labeling.
Indications for Use
The Stryker Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5 mm, 3.0 mm, and 4.0 mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, hand surgery, orthopedic surgery, plastic surgery, and podiatric surgery. These devices are not intended for use in the spine. The Stryker Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications:
- Scaphoid fractures
5
Stryker GmbH
Mini Cannulated Titanium Headed and Headless Screw Set
- Lunate fractures
- Capitate fractures
- Trapezial fractures
- Metacarpal fractures
- Metatarsal fractures
- Phalangeal fractures
- Radial head fractures
- Ulnar styloid fractures
- Small joint fusion
- Osteochondral fractures
- Humeral head fractures
- Glenoid fractures
- Carpometacarpal joint fractures
- Interphalangeal joint fractures
- Tarsal fusions
- Malleolar fractures
- Patellar fractures
- Metaphyseal fractures
- Interfragmentary radius fractures
- Interfragmentary ulnar fractures
- Small hand and wrist bone fractures
- Distal metatarsal osteotomies
- Forefoot interfragmentary fractures
- Midfoot interfragmentary fractures
Summary of Technologies
A comparison of the systems demonstrated that the subject Mini Cannulated Titanium Headed and Headless Bone Screw Set is substantially equivalent to the previously cleared Mini Cannulated Titanium Headed and Headless Bone Screw Set (K120493) in regard to intended use, material, design, and operational principles.
Non-Clinical Testing
This submission does not require non-clinical testing.
Clinical Testing
This submission does not require clinical testing.
Conclusion
The subject Mini Cannulated Titanium Headed and Headless Bone Screw Set is substantially equivalent to the predicate Mini Cannulated Titanium Headed and Headless Bone Set (K120493).