(315 days)
Not Found
No
The 510(k) summary describes a mechanical bone screw system and its performance testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No.
The device, CREED™ Cannulated Screws, is intended to maintain alignment and fixation of bone fractures, which is a structural or supportive function, not a therapeutic one that actively treats or cures a disease or condition.
No
Explanation: The device, CREED™ Cannulated Screws, is described as an implant used for maintaining alignment and fixation of bone fractures. Its intended use is therapeutic (fixation of fractures), not diagnostic (identifying or characterizing disease).
No
The device description clearly states it consists of physical components (screws made of titanium and PEEK) and associated instrumentation, which are hardware.
Based on the provided information, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the CREED™ Cannulated Screws are implants intended for maintaining alignment and fixation of bone fractures. They are physical devices inserted into the body.
- Intended Use: The intended use is for surgical fixation of bone fractures, not for analyzing biological samples.
The information provided describes a surgical implant, which falls under a different category of medical devices than IVDs.
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, 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.
Product codes
HWC
Device Description
CREED™ Cannulated Screws consists of subject components that will be available in thread diameters ranging from Ø2.5mm to Ø7.4 mm and lengths ranging from 14-120mm. They are either headed or headless compression. All screws are self-drilling and self-tapping. The screws are offered in configurations that include a Titanium alloy Ti-6AL-4V ELI (ASTM F136) screw and a Titanium alloy Ti- 6AL-4V ELI (ASTM F136) screw with an outer layer of Zeniva ZA- 600 PEEK (ASTM F2026). 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: Axial pullout strength testing, torque to failure testing and insertion torque testing (ASTM F543). Static and dynamic 3-point bending (ASTM F1264) were also presented in addition to interface bond testing/delamination testing. Torsional resistance testing was performed for characterization. Biocompatibility per ISO 10993 and FDA guidance including cytotoxicity, irritation, sensitization, and chemical characterization were also evaluated.
Key Metrics
Not Found
Predicate Device(s)
K160304, K080850, K082874, K123672
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of the Department of Health & Human Services logo on the left, followed by the FDA logo in blue. The FDA logo includes the text "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
December 16, 2020
GLW Medical Inc % Cheryl Wagoner Consultant Wagoner Consulting LLC 5215 Crosswinds Drive Wilmington, North Carolina 28409
Re: K200291
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 14, 2020 Received: December 16, 2020
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.
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 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200291
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, 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.
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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Traditional 510(k) Premarket Notification CREED™ Cannulated Screws
510(k) Summary for K200291
(as required by 21 CFR 807.92)
| Date Prepared | November 30, 2020 |
|---|---|
| Manufacturer | GLW, Inc. |
| Address | 300 Sylvan Ave |
| Englewood Cliff, NJ 07632 | |
| Telephone | 917-794-2583 |
| Contact Person | Arundhati Radhakrishnan |
| Address | 300 Sylvan Ave |
| Englewood Cliff, NJ 07632 | |
| Telephone | 201-268-3281 |
| Arundhati.radhakrishnan@glwmed.com |
| Trade Name | CREED™ Cannulated Screws |
|---|---|
| Common Name | Screw, Fixation, Bone |
| Panel Code | Orthopaedics/87 |
| Classification Name | Smooth Or Threaded Metallic Bone Fixation Fastener |
| Class | Class II |
| Regulation Number | 21 CFR 888.3040 |
| Product Code | HWC |
| Name of Primary
| Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| OsteoBullet Compression | ||
| Screw | K160304 | Phalanx Innovations |
| Name of Additional Predicate Devices | ||
| DARCO Headless | ||
| Compression Screw | K080850 | Wright Medical Technology Inc. |
| Biomet BioDrive Cannulated | ||
| Screw System | K082874 | Biomet |
| Inion Freedomscrew | K123672 | Inion OY |
| Description | CREEDTM Cannulated Screws consists of subject components that
will be available in thread diameters ranging from Ø2.5mm to Ø7.4 mm and lengths ranging from 14-120mm. They are either headed
or headless compression. All screws are self-drilling and self-
tapping.
The screws are offered in configurations that include a Titanium
alloy Ti-6AL-4V ELI (ASTM F136) screw and a Titanium alloy Ti-
6AL-4V ELI (ASTM F136) screw with an outer layer of Zeniva ZA-
600 PEEK (ASTM F2026). A variety of instrumentation is offered as |
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
4
Traditional 510(k) Premarket Notification
CREED™ Cannulated Screws
| | part of the kit to facilitate delivery of the screws. The screws are
provided sterile via Gamma irradiation. - |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications and
Intended Use | CREEDTM Cannulated Screws are intended to maintain alignment
and fixation of bone fractures, comminuted fractures in the
presence of appropriate additional immobilization such as rigid |
| presence or 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
contains PEEK screws with a titanium alloy core, whereas the
predicate system offers all PEEK screws or all titanium alloy screws
(no mixing of materials in a single screw). |
| Performance Data | Performance data presented in the application included: Axial pullout strength testing, torque to failure testing and insertion torque testing (ASTM F543). Static and dynamic 3-point bending (ASTM F1264) were also presented in addition to interface bond testing/delamination testing. Torsional resistance testing was performed for characterization. Biocompatibility per ISO 10993 and FDA guidance including cytotoxicity, irritation, sensitization, and chemical characterization were also evaluated. |
|---|---|
| ------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 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. |