(28 days)
The Monster BITE 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
The Monster BITE Screw System™ includes snap-off, threaded bone screws offered in 2.0mm and 2.7mm diameters having overall lengths from 8 to 24mm.
Based on the provided FDA 510(k) summary, the device is the "Monster BITE Screw System™". This document is a premarket notification for a medical device and, as such, does not contain the detailed study data typically associated with clinical performance or AI algorithm validation.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than proving clinical efficacy or the device's ability to meet specific performance criteria through empirical studies with clinical endpoints like an AI/ML device would.
Therefore, the requested information regarding acceptance criteria, study data for performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device is not applicable to this document because:
- This is a traditional medical device (metallic bone fixation fastener), not an AI/ML-driven device.
- The demonstration of substantial equivalence relies on material, design, and mechanical performance comparisons to predicate devices, not clinical performance metrics or AI algorithm accuracy.
The document does mention "Performance Data" but clarifies that it refers to theoretical comparisons of torsion and pullout strength along with insertion/removal torque testing per ASTM F543, demonstrating substantial mechanical equivalence to predicate devices, not clinical outcomes in patients or diagnostic accuracy.
In summary, the provided text does not contain the information needed to answer the prompt from the perspective of an AI/ML device's acceptance criteria and performance study because it describes a mechanical bone fixation device applying for 510(k) clearance based on substantial equivalence to existing devices.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2015
Paragon 28, Incorporated % Karen E. Warden, Ph.D. Representative/Consultant BackRoads Consulting, Incorporated P.O. Box 566 Chesterland, Ohio 44026-0566
Re: K153378
Trade/Device Name: Monster BITE Screw System™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 20, 2015 Received: November 23, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) 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 N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K153378
Device Name Monster BITE Screw System™
Indications for Use (Describe)
The Monster BITE 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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510(k) Summary
| Date: | 20 November 2015 |
|---|---|
| Sponsor: | Paragon 28, Inc.4B Inverness Ct. E., STE 280Englewood, Colorado 80112Phone: (888) 728-1888Facsimile: (888) 728-1220 |
| Sponsor Contact: | Frank S. Bono, Chief Technology Officer |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads ConsultingPO Box 566Chesterland, OH 44026Office: 440.729.8457 |
| Trade Names: | Monster BITE Screw System™ |
| Device Classification | Class II |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Regulation: | 888.3040 |
| Device Product Code: | HWC |
| Submission Purpose: | This submission addresses modified dimensions of the cleared MonsterScrew components and adds the Monster BITE Screw System to theMonster Screw System™ family. |
| Device Description: | The Monster BITE Screw System™ includes snap-off, threaded bonescrews offered in 2.0mm and 2.7mm diameters having overall lengthsfrom 8 to 24mm. |
| Intended Use: | The Monster BITE Screw System™ is indicated for use in bonereconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation,fracture repair and fracture fixation, appropriate for the size of the device. |
| Materials: | The Monster BITE Screw System™ implants are manufactured frommedical grade titanium alloy (per ASTM F136). |
| Predicate Devices: | Primary: Paragon 28 (K151418) |
| Reference Devices: | Paragon 28 (K124027)Smith & Nephew (K090675)OsteoMed Corp. (K924018) |
| Performance Data: | Theoretical comparisons of torsion and pullout strength along withinsertion/removal torque testing per ASTM F543 demonstrated theMonster BITE Screw System™ mechanical performance to besubstantially equivalent to the predicate devices. |
| TechnologicalCharacteristics: | The Monster BITE Screw System™ possesses the same technologicalcharacteristics as one or more of the predicate devices. These include:• performance (as described above),• basic design (threaded fastener),• material (titanium alloy) and• sizes (dimensions are comparable to those offered by thepredicate systems).Therefore the fundamental scientific technology of the Monster BITEScrew System™ is the same as previously cleared devices. |
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The Monster BITE Screw System™ possesses the same intended use
and technological characteristics as the predicate devices. Therefore the Conclusion: Monster BITE Screw System™ is substantially equivalent for its intended use.
§ 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.