(48 days)
No
The summary describes a mechanical bone screw system with no mention of software, image processing, or AI/ML terms.
Yes
The device is clearly indicated for medical purposes such as bone reconstruction, fracture repair, and joint fusion, which are therapeutic interventions.
No
The device description and intended use indicate that the Monster Screw System™ is a surgical implant used for bone reconstruction and fixation, not for diagnosing conditions. It is a therapy device.
No
The device description explicitly states it is comprised of bone screws and washers, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Monster Screw System™ is for surgical procedures involving bone (reconstruction, osteotomy, fracture repair, etc.). This is a therapeutic device used in vivo (within the body).
- Device Description: The device is comprised of bone screws and washers, which are physical implants.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Monster Screw System™ does not perform any such function.
The information provided clearly describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Monster Screw System™ is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
The Monster Screw System™ is comprised of bone screws and washers. The Monster Screw is a threaded bone screw offered in 2.0mm to 9.5mm diameters (in 0.5 mm increments) having overall lengths from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are offered having a variety of features with respect to head, thread, tip, cannulation and material. Size-matched washers are also available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Theoretical comparisons demonstrated the Monster Screw System™ mechanical performance to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Paragon 28 (K124027)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Vilex Inc (K973309, K991151, K991197 and K014154), OsteoMed Corp. (K924018)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized image 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
July 15, 2015
Paragon 28 % Karen Warden, Ph.D. Backroads Consulting, Inc P.O. Box 566 Chesterland, Ohio 44026-0566
Re: K151418 Trade/Device Name: Monster Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: June 16, 2015 Received: June 17, 2015
Dear Dr. Warden:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 yours,
Mark N. Melkerson -S
Mark 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 on last page.
510(k) Number (if known)
Device Name Monster Screw System™
Indications for Use (Describe)
The Monster Screw System™ is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Section 8 – 510(k) Summary
| Date: | 26 May 2015 |
|---|---|
| Sponsor: | Paragon 28, Inc. |
| 4B Inverness Ct. E., STE 280 | |
| Englewood, Colorado 80112 | |
| Phone: (888) 728-1888 | |
| Facsimile: (888) 728-1220 | |
| Sponsor Contact: | Frank S. Bono, Chief Technology Officer |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Trade Names: | Monster Screw System™ |
| Device Classification | Class II |
| Classification Name: | Smooth or threaded metallic bone fixation fastener, Single/multiple |
| component metallic bone fixation appliances and accessories | |
| Regulation: | 888.3040, 888.3030 |
| Device Product Code: | HWC, HTN |
| Submission Purpose: | This submission addresses modified dimensions of the cleared 2.0 |
| Monster Screw components. | |
| Device Description: | The Monster Screw System™ is comprised of bone screws and washers. |
| The Monster Screw is a threaded bone screw offered in 2.0mm to 9.5mm | |
| diameters (in 0.5 mm increments) having overall lengths from 8mm (for | |
| smaller diameters) thru 200mm (for larger diameters). The screws are | |
| offered having a variety of features with respect to head, thread, tip, | |
| cannulation and material. Size-matched washers are also available. | |
| Intended Use: | The Monster Screw System™ is indicated for use in bone reconstruction, |
| osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and | |
| fracture fixation, appropriate for the size of the device. | |
| Materials: | The Monster Screw System™ implants are manufactured from medical |
| grade titanium alloy (per ASTM F136) and stainless steel alloy (per | |
| ASTM F2229). | |
| Predicate Devices: | Primary: Paragon 28 (K124027) |
| Reference: | |
| Vilex Inc (K973309, K991151, K991197 and K014154) | |
| OsteoMed Corp. (K924018) | |
| Performance Data: | Theoretical comparisons demonstrated the Monster Screw System™ |
| mechanical performance to be substantially equivalent to the predicate | |
| devices. | |
| Technological | |
| Characteristics: | The Monster Screw System™ possesses the same technological |
| characteristics as one or more of the predicate devices. These include: | |
| performance (as described above), basic design (threaded fastener), material (titanium and/or stainless steel alloys) and sizes (dimensions are comparable to those offered by the | |
| predicate systems). Therefore the fundamental scientific technology of the Monster Screw | |
| System™ is the same as previously cleared devices. | |
| Conclusion: | The Monster Screw System™ possesses the same intended use and |
| technological characteristics as the predicate devices. Therefore the | |
| Monster Screw System™ is substantially equivalent for its intended use. |
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