(43 days)
No
The summary describes a system of bone screws and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The performance studies focus on non-clinical testing of the physical device properties.
Yes
The device is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair, and fracture fixation, which are all therapeutic interventions for various musculoskeletal conditions.
No
Explanation: The Monster® Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, which are all treatment and repair procedures, not diagnostic ones.
No
The device description explicitly states that the system contains bone screws, which are physical hardware components.
Based on the provided information, the Monster® Screw System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device's function in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair, and fracture fixation. These are all surgical procedures performed directly on the patient's body.
- Device Description: The device is described as bone screws, which are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Monster® Screw System is used in vivo (inside the body) for surgical repair and fixation.
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 device. Specific examples include: Fractures and Osteotomies - · Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc) - · Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture) - · Talar fractures - · Ankle fractures - Navicular fractures - · Fractures of the fibula, malleolus, and calcaneus - · Metatarsal and phalangeal osteotomies - · Weil osteotomy - · Calcaneal osteotomy Hallux Valgus Correction - · Fixation of osteotomies (i.e. Akin, Scarf, Chevron) - Interphalangeal (IP) arthrodesis - · Proximal, midshaft, or distal osteotomy - Lapidus arthrodesis Arthrodesis/Deformity Correction - 1st MTP arthrodesis - Metatarsal deformity correction - · Tarsometatarsal joint arthrodesis - · Naviculocuneiform joint arthrodesis - · Talonavicular arthrodesis - Subtalar joint arthrodesis - · Triple arthrodesis - Medial column arthrodesis - Subtalar joint distraction arthrodesis - · Ankle arthrodesis - · Lateralizing calcaneal osteotomy - Lateral column lengthening - · Hammertoe Fusion resulting from neuropathic osteoarthropathy (Charcot) such as: - Medial and lateral column - · Subtalar, talonavicular, and calcaneocuboid
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Monster Screw System contains bone screws of various diameters, lengths, and configurations. One configuration is a snap-off style bone screw offered in two diameters having various overall and threaded lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, tarsals, metatarsals, foot, talar, ankle, navicular, fibula, malleolus, calcaneus, phalangeal, interphalangeal (IP), MTP, tarsometatarsal joint, naviculocuneiform joint, talonavicular, subtalar joint, medial column, calcaneocuboid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-clinical testing used to support equivalence included: sterilization (ISO 11137-1), cleaning validation (ASTM F2459), cytotoxicity (ISO 10993-5), bacterial endotoxins (ANSI/AAMI ST72), distribution validation (ASTM D4169) assessed via visual inspection (ASTM F1886), seal strength (ASTM F88), and bubble leak evaluations (ASTM F2096), and shelf-life validation assessed via visual inspection (ASTM F1886), seal strength (ASTM F88), and dye leak evaluations (ASTM F1929).
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.
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.
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
November 13, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, with 'ADMINISTRATION' written below in a smaller font.
Paragon 28, Inc. Haylie Hertz Regulatory Affairs Specialist 14445 Grasslands Dr. Englewood, Colorado 80112
Re: K203011
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 Dated: September 29, 2020 Received: October 1, 2020
Dear Haylie Hertz:
We have reviewed vour 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.
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
1
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, 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
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Indications for Use
510(k) Number (if known) K203011
Device Name Monster® Screw System
Indications for Use (Describe)
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 device. Specific examples include:
Fractures and Osteotomies
- · Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc)
- · Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture)
- · Talar fractures
- · Ankle fractures
- Navicular fractures
- · Fractures of the fibula, malleolus, and calcaneus
- · Metatarsal and phalangeal osteotomies
- · Weil osteotomy
- · Calcaneal osteotomy
Hallux Valgus Correction
- · Fixation of osteotomies (i.e. Akin, Scarf, Chevron)
- Interphalangeal (IP) arthrodesis
- · Proximal, midshaft, or distal osteotomy
- Lapidus arthrodesis
Arthrodesis/Deformity Correction
- 1st MTP arthrodesis
- Metatarsal deformity correction
- · Tarsometatarsal joint arthrodesis
- · Naviculocuneiform joint arthrodesis
- · Talonavicular arthrodesis
- Subtalar joint arthrodesis
- · Triple arthrodesis
- Medial column arthrodesis
- Subtalar joint distraction arthrodesis
- · Ankle arthrodesis
- · Lateralizing calcaneal osteotomy
- Lateral column lengthening
- · Hammertoe
Fusion resulting from neuropathic osteoarthropathy (Charcot) such as:
- Medial and lateral column
- · Subtalar, talonavicular, and calcaneocuboid
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
| 510(k) Number: | K203011 |
|---|---|
| Device Trade Name: | Monster Screw System |
| Manufacturer: | Paragon 28, Inc. |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Contact: | Haylie Hertz |
| Phone: 303-720-0017 | |
| hhertz@paragon28.com | |
| Date Prepared: | November 13, 2020 |
| Common Name: | Bone Screw |
| Classification: | 21 CFR 888.3040, smooth or threaded bone fixation fastener |
| Class: | II |
| Product Code: | HWC |
| Predicate Device: | Monster Screw System (K190586) |
| Reference Devices: | Hammertoe Compression System (K183228) |
| JAWS Nitinol Staple System (K170923) |
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. Specific examples include:
Fractures and Osteotomies
- Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc) .
- Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture) ●
- . Talar fractures
- Ankle fractures
- Navicular fractures
- Fractures of the fibula, malleolus, and calcaneus
- Metatarsal and phalangeal osteotomies ●
- Weil osteotomy
- Calcaneal osteotomy ●
Hallux Valgus Correction
- Fixation of osteotomies (i.e. Akin, Scarf, Chevron) ●
- Interphalangeal (IP) arthrodesis .
- Proximal, midshaft, or distal osteotomy
- Lapidus arthrodesis ●
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Arthrodesis/Deformity Correction
- 1st MTP arthrodesis
- Metatarsal deformity correction ●
- Tarsometatarsal joint arthrodesis ●
- Naviculocuneiform ioint arthrodesis ●
- Talonavicular arthrodesis
- Subtalar joint arthrodesis
- Triple arthrodesis
- Medial column arthrodesis
- Subtalar joint distraction arthrodesis
- . Ankle arthrodesis
- Lateralizing calcaneal osteotomy
- Lateral column lengthening
- Hammertoe
Fusion results from neuropathic osteoarthropathy (Charcot) such as:
- Medial and lateral column ●
- Subtalar, talonavicular, and calcaneocuboid
Device Description:
The Monster Screw System contains bone screws of various diameters, lengths, and configurations. One configuration is a snap-off style bone screw offered in two diameters having various overall and threaded lengths.
Substantial Equivalence:
The intended use of the modified device, as described in its labeling, has not changed as a result of the modifications proposed in the present submission. In addition, the subject device possesses the same technological characteristics as the predicate device, including performance, basic design, material, manufacturing, and sizes. Differences between the Monster screws and the predicate device were shown not to raise new questions of safety and effectiveness. Therefore, the Monster Screw System is substantially equivalent to the predicate device cited on the previous page with respect to indications, design, function, and performance.
Non-clinical Testing:
Non-clinical testing used to support equivalence included: sterilization (ISO 11137-1), cleaning validation (ASTM F2459), cytotoxicity (ISO 10993-5), bacterial endotoxins (ANSI/AAMI ST72), distribution validation (ASTM D4169) assessed via visual inspection (ASTM F1886), seal strength (ASTM F88), and bubble leak evaluations (ASTM F2096), and shelf-life validation assessed via visual inspection (ASTM F1886), seal strength (ASTM F88), and dye leak evaluations (ASTM F1929).
Clinical Testing:
Clinical testing was not necessary to support equivalence.
Conclusion:
The Monster Screw System possesses the same intended use and technological characteristics as the predicate device. Therefore, the Monster Screw System is substantially equivalent for its intended use.