(89 days)
No
The 510(k) summary describes a mechanical bone fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions, which are all therapeutic interventions for medical conditions.
No
The device description and intended use clearly state that it is a system for fixation of fractures, fusions, and osteotomies, which are therapeutic interventions, not diagnostic procedures.
No
The device description clearly states that the Bone Bolt System consists of physical components (bolts, nut-sleeves, washers) which are implanted into bone. This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for the fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as bolts and nut-sleeves that are implanted into bone. This is a physical implant used for structural support.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical fixation.
N/A
Intended Use / Indications for Use
The 3.5mm, 4.0mm and 4.5mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bone fragments, long bones, and long bone fragments of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, and fibula, and the bones of the hand and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation.
The 5.0mm, 6.0mm and 7.0mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments of humerus, radius, ulna, tibia, femur and fibula, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
The Bone Bolt System consists of various sizes and lengths of bolts and nut-sleeves, which are implanted from opposing bone surfaces to provide stabilization of bones and bone fragments for the fixation of fractures, arthrodeses, and osteotomies. The bolts and nut-sleeves are cannulated for use with guidewires for precise placement in bone. The Bone Bolt System includes optional washers of various sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bone fragments, long bones, and long bone fragments of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, and fibula, and the bones of the hand; long bones and long bone fragments of humerus, radius, ulna, tibia, femur and fibula, pelvis, sacrum, and the bones of the foot.
Indicated Patient Age Range
Adults and in both children (2-12 years) and adolescents (12-21 years)
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)
The Bone Bolt System performance was characterized through the following tests, in accordance with ASTM F543-17 and ASTM F1264-16 Annex A4:
- Torsional Strength Testing
- Driving Torque Testing
- Axial Pull-out Strength Testing
- Static and Dynamic Bending Testing
Side-by-side performance testing demonstrates that the Bone Bolt System has equivalent or statistically significantly better performance than its predicates. No clinical or animal testing was conducted.
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.
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June 26, 2023
Image /page/0/Picture/1 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
University of Utah, Department of Orthopaedics % Hollace Rhodes Vice President MCRA, LLC 803 7th Street NW, 3rd Floor Washington, District of Columbia 20001
Re: K230867
Trade/Device Name: Bone Bolt 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 29, 2023 Received: March 29, 2023
Dear Hollace Rhodes:
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.
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 mediation-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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Indications for Use
510(k) Number (if known) K230867
Device Name Bone Bolt System
Indications for Use (Describe)
The 3.5mm, 4.0mm and 4.5mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bone fragments, long bones, and long bone fragments of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, and fibula, and the bones of the hand and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation.
The 5.0mm, 6.0mm and 7.0mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments of humerus, radius, ulna, tibia, femur and fibula, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation.
| 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)
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Image /page/3/Picture/0 description: The image shows the logo for The University of Utah. On the left side of the logo is a large red block U. To the right of the U is the text "THE UNIVERSITY OF UTAH" stacked on top of each other.
510(k) Summary
| Device Trade Name: | Bone Bolt System |
|---|---|
| Sponsor: | University of Utah, Department of Orthopaedics |
| 590 Wakara Way | |
| Salt Lake City, UT 84108 | |
| Contact: | T. Wade Fallin, M.S. |
| Research Professor | |
| Phone: (801) 587-2938 | |
| Fax: (801) 587-5411 | |
| Prepared by: | MCRA, LLC |
| Date Prepared: | June 26, 2023 |
| Common Names: | Screw, Fixation, Bone |
| Washer, Bolt Nut | |
| Classifications: | 21 CFR 888.3040 |
| 21 CFR 888.3030 | |
| Class: | II |
| Product Codes: | HWC |
| HTN |
Indications for Use:
The 3.5mm, 4.0mm and 4.5mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, nonunions, and malunions of small bone fragments, long bones, and long bone fragments of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, and fibula, and the bones of the hand and foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation.
The 5.0mm, 6.0mm and 7.0mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, nonunions, and malunions of long bone fragments of humerus, radius, ulna, tibia, femur and fibula, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation.
Device Description:
The Bone Bolt System consists of various sizes and lengths of bolts and nut-sleeves, which are implanted from opposing bone surfaces to provide stabilization of bones and bone fragments for the fixation of fractures, arthrodeses, and osteotomies. The bolts and nut-sleeves are cannulated for use with guidewires for precise placement in bone. The Bone Bolt System includes optional washers of various sizes.
Predicate Devices:
Primary Predicate DePuy Synthes Cortex and Cannulated Screws (K161616)
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Image /page/4/Picture/0 description: The image shows the logo for The University of Utah. On the left is a large red block U. To the right of the U is the text "THE UNIVERSITY OF UTAH" in a serif font.
Additional Predicate Synthes 3.5mm Cortex Screws (K043185)
Reference Device Acumed Frag-Loc® System (K130986)
Materials:
The Bone Bolt implants are made from Ti-6Al-4V per ASTM F136. The Bone Bolt accessories are made from stainless steel per ASTM F899, polypropylene and silicone.
Performance Data:
The Bone Bolt System performance was characterized through the following tests, in accordance with ASTM F543-17 and ASTM F1264-16 Annex A4:
- Torsional Strength Testing
- Driving Torque Testing
- Axial Pull-out Strength Testing
- Static and Dynamic Bending Testing
No clinical or animal testing was conducted.
Substantial Equivalence:
The Bone Bolt System has the same intended use and uses the same design, materials, principles of operations, and similar range of sizes as the predicate devices, the DePuy Synthes Cortex and Cannulated Screws (K1616), and Synthes 3.5mm Cortex Screws (K043185). Side-by-side performance testing demonstrates that the Bone Bolt System has equivalent or statistically significantly better performance than its predicates. The Bone Bolt System's similarities in technological characteristics to its predicates and the reference device, the Acumed Frag-Loc® System (K130986), further support its substantial equivalence. Thus, the Bone Bolt System is substantially equivalent to the DePuy Synthes Cortex and Cannulated Screws (K161616), Synthes 3.5mm Cortex Screws (K043185).