(34 days)
Not Found
No
The device description and intended use are for a mechanical implant (screws) and do not mention any software, algorithms, or data processing capabilities that would suggest AI/ML.
No
The device is a medical implant (screws) used for fixation of bone fractures, which is a structural or supportive function, not a therapeutic one that treats a disease or condition directly.
No
Explanation: The device, CREED™ Cannulated Screws, is described as an implant used to maintain alignment and fixation of bone fractures. Its function is to provide structural support rather than to diagnose medical conditions or provide information for diagnosis.
No
The device description explicitly states it consists of physical components (screws made of Titanium alloy) and instrumentation, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device description: The description clearly states that the CREED™ Cannulated Screws are implants used to fix bone fractures. They are physical devices inserted into the body.
- Intended Use: The intended use is to maintain alignment and fixation of bone fractures, which is a surgical procedure, not a diagnostic test performed on a specimen.
Therefore, based on the provided information, the CREED™ Cannulated Screws are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CREED™ Cannulated Screws are intended to maintain alignment and fixation of bone fractures in the presence of appropriate additional immobilization such as rigid fixation implants, cast or brace, nonunions, osteotomies, arthrodesis or bone grafts in the hand, foot, and ankle including distal tibia and fibula. These implants are not intended for spinal use.
Product codes
HWC
Device Description
CREED™ Cannulated Screws Subject device consists of components that will be available in Ø2.5mm thread diameter and lengths ranging from 20-44 mm. They areheadless compression screws. All screws are self-drilling and self-tapping. The screws are Titanium alloy Ti-6AL-4V ELI (ASTM F136) screws. A variety of instrumentation is offered as part of the kit to facilitate delivery of the screws. The screws are provided sterile via Gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, foot, and ankle including distal tibia and fibula
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance data presented in the application included: Static bending (ASTM F1264) test results were presented along with engineering rationale for other relevant measures.
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
January 25, 2023
Image /page/0/Picture/9 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.
GLW, Inc. % Cheryl Wagoner Principal Consultant Wagoner Consulting LLC 5215 Crosswinds Drive Wilmington, North Carolina 28409
Re: K223847
Trade/Device Name: CREED™ Cannulated Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: December 21, 2022 Received: December 22, 2022
Dear Cheryl Wagoner:
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.
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name CREED™ Cannulated Screws
Indications for Use (Describe)
CREED™ Cannulated Screws are intended to maintain alignment and fixation of bone fractures in the presence of appropriate additional immobilization such as rigid fixation implants, cast or brace, nonunions, osteotomies, arthrodesis or bone grafts in the hand, foot, and ankle including distal tibia and fibula. These implants are not intended for spinal use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
|X| Prescription Use (Part 21 CFR 801 Subpart D)
D Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
(as required by 21 CFR 807.92)
| Submitter | GLW Medical Innovation |
|---|---|
| Address | 300 Sylvan Ave |
| Englewood Cliff, NJ 07632 | |
| Telephone | 9170794-2583 |
| Contact Person | Arundhati Radhakrishnan |
| Address | 300 Sylvan Ave |
| Englewood Cliff, NJ 07632 | |
| Telephone | 201-268-3281 |
| Arundhati.radhakrishnan@glwmed.com | |
| Date Prepared | January 23, 2023 |
| Trade Name | CREED™ Cannulated Screws |
| Common Name | Screw, Fixation, Bone |
| Panel Code | Orthopaedics/87 |
| Classification | 21 CFR 888.3040 Smooth or threaded metallic bone |
| Class | Class II |
| Product Code | HWC: Screw, fixation, bone |
| Predicate Device (primary) | |
| CREED™ Cannulated Screws | K200291 |
| GLW Medical Innovation | |
| Description | CREED™ Cannulated Screws Subject device consists of components |
| that will be available in Ø2.5mm thread diameter and lengths ranging | |
| from 20-44 mm. They areheadless compression screws. All screws are | |
| self-drilling and self-tapping. | |
| The screws are Titanium alloy Ti-6AL-4V ELI (ASTM F136) screws. A | |
| variety of instrumentation is offered as part of the kit to facilitate delivery | |
| of the screws. The screws are provided sterile via Gamma irradiation. | |
| Indications and | |
| Intended Use | CREED™ Cannulated Screws are intended to maintain alignment and |
| fixation of bone fractures, comminuted fractures in the presence of | |
| appropriate additional immobilization such as rigid fixation implants, cast | |
| or brace, non-unions, osteotomies, arthrodesis or bone grafts in the hand, | |
| foot, and ankle including distal tibia and fibula. These implants are not | |
| intended for spinal use. | |
| Technological | |
| Characteristics | |
| and Substantial | |
| Equivalence | Documentation was provided to demonstrate that the Subject device is |
| substantially equivalent to the predicate devices. The Subject device is | |
| substantially equivalent to the predicate devices in intended use, | |
| indications for use, materials, technological characteristics, and labeling. | |
| The Subject device is similar in size and thread form as the predicate(s). | |
| The Subject and predicate both contain Ti-alloy screws. The subject | |
| device differs from the predicate because it offers a wider range of screw | |
| lengths as compared to the predicate. | |
| Performance Data | Performance data presented in the application included: Static bending |
| (ASTM F1264) test results were presented along with engineering | |
| rationale for other relevant measures. | |
| Conclusion | Based on the intended use, indications for use, technological characteristics, materials, and performance comparison to predicate devices, the Subject device has been shown to be substantially equivalent to legally marketed predicate devices. |
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