(30 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of bone screws and nuts, with no mention of AI or ML capabilities.
Yes
The device is intended for fixation of fractures and non-unions, which are therapeutic interventions.
No
The device is described as cannulated screws and nuts intended for fixation of fractures and non-unions, which are used in treatment, not diagnosis. It does not mention any diagnostic capabilities or functions.
No
The device description explicitly states it consists of physical components (cannulated screws and nuts) made from Stainless Steel or Titanium.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The OsteoCentric Cannulated Fasteners and Nuts are described as surgical implants (screws and nuts) made of metal. Their intended use is for the fixation of fractures and non-unions of bones and bone arthrodesis. This is a direct surgical intervention on the body, not a test performed on a sample outside the body.
The information clearly indicates a device used within the body for structural support and fixation, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The OsteoCentric 2.4mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
The OsteoCentric Trauma 7.0mm and 8.0mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis.
The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e.- the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nut-and-bolt system, as discussed above.
Product codes
HWC, HTN
Device Description
The OsteoCentric Technologies Cannulated Fasteners and Nuts within the product line of the SMV Scientific Cannulated Screws consists of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws and nuts are provided non-sterile. The screws and nuts are manufactured from Stainless Steel per ASTM F138 or from Titanium per ASTM F136 or F1295.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones, large bones, scaphoid, carpal, metacarpal, phalangeal, femoral neck, tibial plateau, ankle, intercondylar femur, subtalar.
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
Non-clinical analysis and testing included:
- Engineering analysis of torsional strength .
- Engineering analysis of pullout resistance .
- Driving torque testing per ASTM F543 .
- Instrument Cleaning Validation per AAMI TIR12:2010 and ANSI/AAMI TIR30:2011 .
- Sterilization Validation per AAMI TIR12:2010 .
Key Metrics
Not Found
Predicate Device(s)
K170021, K202680, K191344, K000080, K081813, K150981
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
April 14, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two main elements: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized representation of an eagle. The FDA acronym is in a blue square, and the full name of the agency is written in blue letters.
OsteoCentric Technologies % Nathan Wright Engineer & Regulatory Special Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K210754
Trade/Device Name: Cannulated Fasteners and Nuts 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 12, 2021 Received: March 15, 2021
Dear Nathan Wright:
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. 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.
1
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 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 -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known) K210754 Device Name
Cannulated Fasteners and Nuts
Indications for Use (Describe)
The OsteoCentric 2.4mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
The OsteoCentric Trauma 7.0mm and 8.0mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis.
The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e.- the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nut-and-bolt system, as discussed above.
Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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| 510(K) SUMMARY |
|---|
| Submitter's Name: | OsteoCentric Technologies |
|---|---|
| Submitter's Address: | 75 West 300 North, Suite #150 |
| Logan, UT 84321 | |
| Submitter's Telephone: | 1-800-969-0639 |
| Contact Person: | Nathan Wright, MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | April 12, 2021 |
| Trade or Proprietary Name: | Cannulated Fasteners and Nuts |
| Common or Usual Name: | Screw, Fixation, Bone (primary) and |
| Washer, Bolt Nut | |
| Device Classification Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| (primary) and | |
| Single/multiple component metallic bone fixation | |
| appliances and accessories | |
| Classification: | Class II per 21 CFR §888.3040 (primary) and |
| §888.3030 | |
| Product Code: | HWC (primary), HTN |
| Classification Panel: | Orthopedic |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The OsteoCentric Technologies Cannulated Fasteners and Nuts within the product line of the SMV Scientific Cannulated Screws consists of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws and nuts are provided non-sterile. The screws and nuts are manufactured from Stainless Steel per ASTM F138 or from Titanium per ASTM F136 or F1295.
INDICATIONS FOR USE
The OsteoCentric 2.4mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
The OsteoCentric Trauma 7.0mm and 8.0mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis.
The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase
4
the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e. - the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nutand-bolt system, as discussed above.
TECHNICAL CHARACTERISTICS
The indications for use for the OsteoCentric Cannulated Fasteners and Nuts are same as that of the SMV Scientific Cannulated Bone Screws. The OsteoCentric Cannulated Fasteners and Nuts are made from stainless steel per ASTM F138 and from titanium per ASTM F136 or F1295. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- . Indications for Use
- Materials of manufacture .
- Principles of operation
- Sizes
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K170021 | SMV Scientific Cannulated Bone Screws | SMV Scientific | Primary |
| K202680 | ExtremiFix Mini & Small | ||
| Cannulated Screw System | OsteoMed LLC | Additional | |
| K191344 | Arthrex Mini Comprehensive | ||
| Fixation System – 2.0mm & 2.4mm | |||
| Module | Arthrex Inc. | Additional | |
| K000080 | Asnis III Cannulated Screw System | Howmedica | |
| Osteonics Corp. | Additional | ||
| K081813 | CompresSURE Fracture Repair | ||
| System | U.S. Implant | ||
| Solutions, LLC | Additional | ||
| K150981 | SMV Scientific Bone Screws | SMV Scientific | Additional |
PERFORMANCE TESTING SUMMARY
In support of this Special 510(k) Device Modification Premarket Notification, OsteoCentric Technologies has conducted mechanical testing with engineering analyses and geometric comparisons to demonstrate that the modifications to the SMV Scientific Cannulated Screws provide adequate and substantially equivalent mechanical performance (torsional strength, driving torque, and pullout strength) for their intended use. Non-clinical analysis and testing included:
- Engineering analysis of torsional strength .
- Engineering analysis of pullout resistance .
5
- Driving torque testing per ASTM F543 .
- Instrument Cleaning Validation per AAMI TIR12:2010 and ANSI/AAMI TIR30:2011 .
- Sterilization Validation per AAMI TIR12:2010 .
CONCLUSION
The subject OsteoCentric Cannulated Fasteners and Nuts are very similar to previously cleared Cannulated Screws (K170021). The indications for use for the subject are the same to that of the previously cleared predicates. The subject screws have similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications of additional sizes and inclusion of nuts raise no new types of safety or effectiveness questions. The overall technology characteristics and mechanical performance evaluation lead to the conclusion that the OsteoCentric Cannulated Fasteners and Nuts are substantially equivalent to the predicate devices.