(98 days)
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.
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 in flat, dome and bowl configurations.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Monster Screw System™":
It is important to note that this submission (K124027) is for a medical device (bone fixation screws), not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical AI/SaMD study parameters (like multi-reader multi-case studies, standalone performance, training sets, ground truth methodology for AI models, etc.) are not applicable in this context. The "acceptance criteria" and "study" refer to mechanical performance testing against established industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Worst Case Monster Screws) |
|---|---|
| Torsion (ASTM F543) | Passed (demonstrated substantial equivalence) |
| Insertion/Removal (ASTM F543) | Passed (demonstrated substantial equivalence) |
| Pullout (ASTM F543) | Passed (demonstrated substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of screws or tests performed. It generically states "Mechanical testing of the worst case Monster Screws."
- Data Provenance: Not applicable in the context of mechanical testing of physical devices. The testing was performed on newly manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for mechanical testing is established by compliance with a predetermined engineering standard (ASTM F543), not by expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable for mechanical testing. Data is quantitative and compared directly to the specified standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
No, an MRMC study was not done. This device is a bone fixation screw system, not an AI/SaMD.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for determining device performance was compliance with the specified mechanical testing standards: ASTM F543 (Standard Specification for Metallic Medical Bone Screws). This standard provides quantitative thresholds and methodologies for measuring torsion, insertion/removal force, and pullout strength.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for mechanical testing of physical devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
Summary of the Study Proving Acceptance Criteria:
The study conducted to demonstrate that the Monster Screw System™ meets the acceptance criteria was focused on mechanical performance testing.
- Study Design: Mechanical testing was performed on "worst case Monster Screws." The specific test methodologies were in accordance with ASTM F543.
- Tests Performed:
- Torsion testing
- Insertion/removal testing
- Pullout testing
- Acceptance Criteria: The device's performance was considered acceptable if its mechanical properties (torsion, insertion/removal, pullout) were "substantially equivalent" to predicate devices, as demonstrated by the results of the ASTM F543 tests. This implies that the measured values met or exceeded the performance of the predicate devices in these defined mechanical parameters, which themselves would have been shown to meet the ASTM F543 standard.
- Results: The mechanical test results, along with "theoretical comparisons," "demonstrated that the Monster Screw System™ mechanical performance is substantially equivalent to the predicate devices."
- Conclusion: Based on these mechanical tests, the sponsor concluded that the device possesses the same technological characteristics (including performance) as the predicate devices and is therefore substantially equivalent for its intended use.
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K124027 Page 1/2
Section 8 – 510(k) Summary
APR 0 5 2013
| Date: | 27 December 2012 |
|---|---|
| Sponsor: | Apogee OrthoSolutions, LLC2513 Greenview Drive,Uniontown, OH 44685Phone: 330.899.0881 |
| Contact Person: | Spanky Raymond, Manager |
| Trade Names: | Monster Screw System™ |
| Device Classification | Class II |
| Classification Name: | Smooth or threaded metallic bone fixation fastener, Single/multiplecomponent metallic bone fixation appliances and accessories |
| Regulation: | 888.3040, 888.3030 |
| Device ProductCode: | HWC, HTN |
| Device Description: | The Monster Screw System™ is comprised of bone screws andwashers. The Monster Screw is a threaded bone screw offered in2.0mm to 9.5mm diameters (in 0.5 mm increments) having overalllengths from 8mm (for smaller diameters) thru 200mm (for largerdiameters). The screws are offered having a variety of features withrespect to head, thread, tip, cannulation and material. Size-matchedwashers are also available in flat, dome and bowl configurations. |
| Intended Use: | The Monster Screw System™ is indicated for use in bonereconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation,fracture repair and fracture fixation, appropriate for the size of thedevice. |
| Materials: | The Monster Screw System™ implants are manufactured frommedical grade titanium alloy (per ASTM F136) and stainless steelalloy (per ASTM F2229). |
| Predicate Devices: | Vilex Inc (K973309, K991151, K991197 and K014154)OsteoMed Corp. (K924018)OrthoHelix (K060428)Zimmer, Inc. (K112885 [with Pioneer K102903])Smith & Nephew (K060736, K090675 and K111994)Synthes, Inc. (K962011, K962823, K963172, K012945, K021932,K050636 and K090949) |
| Performance Data: | Mechanical testing of the worst case Monster Screws includedtorsion, insertion/removal and pullout performed according to ASTMF543. The mechanical test results and theoretical comparisonsdemonstrated that the Monster Screw System™ mechanicalperformance is substantially equivalent to the predicate devices. |
·
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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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Image /page/2/Picture/0 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter dated: April 5, 2013
Apogee OrthoSolutions, LLC % Mr. Spanky Raymond Manager 2513 Greenview Drive Uniontown, Ohio 44685
Re: K124027
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: March 7, 2013 Received: March 8, 2013
Dear Mr. Raymond:
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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Page 2 - Mr. Spanky Raymond
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 NEMAkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 7 - Indications for Use Statement
510(k) Number:_K124027
Device Name: Monster Screw System™
Indications for 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.
Prescription Use _ X OR Over-the-Counter Use_ . (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabet际视频rank -S
Division of Orthopedic Devices
Page 13
§ 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.