(98 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and physical components of bone screws and washers. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, all of which are considered therapeutic applications.
No
The device is described as a system of bone screws and washers used for fixation and reconstruction, which are therapeutic and structural functions rather than diagnostic.
No
The device description explicitly states that the device 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 clearly describes a device used in the body for surgical procedures (bone reconstruction, fracture repair, etc.). IVDs are used outside the body to examine specimens (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description details physical implants (bone screws and washers) designed to be surgically placed. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
N/A
Intended Use / 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.
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 in flat, dome and bowl configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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)
Mechanical testing of the worst case Monster Screws included torsion, insertion/removal and pullout performed according to ASTM F543. The mechanical test results and theoretical comparisons demonstrated that the Monster Screw System™ mechanical performance is 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.
K973309, K991151, K991197, K014154, K924018, K060428, K112885, K102903, K060736, K090675, K111994, K962011, K962823, K963172, K012945, K021932, K050636, K090949
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.
Not Found
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.
0
K124027 Page 1/2
Section 8 – 510(k) Summary
APR 0 5 2013
| Date: | 27 December 2012 |
|---|---|
| Sponsor: | Apogee OrthoSolutions, LLC |
| 2513 Greenview Drive, | |
| Uniontown, OH 44685 | |
| Phone: 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/multiple |
| component metallic bone fixation appliances and accessories | |
| Regulation: | 888.3040, 888.3030 |
| Device Product | |
| Code: | 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 in flat, dome and bowl configurations. | |
| 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: | 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 included |
| torsion, insertion/removal and pullout performed according to ASTM | |
| F543. The mechanical test results and theoretical comparisons | |
| demonstrated that the Monster Screw System™ mechanical | |
| performance is substantially equivalent to the predicate devices. |
·
1
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.
2
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
3
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
4
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