The Intraosseous Fusion Device System is indicated for use in skeletally mature individuals for fracture repair and arthrodesis, osteotomy, joint fusion and fragment fixation appropriate with the size of the implant including:

Minimally invasive reconstruction of fractures and joints; Fractures of the foot and ankle; Osteochrondritis dissecans, Ostero-Chondral Fractures, Other small fragment, cancellous bone fractures, Small joint fusion. Metatarsal and phalangeal osteotomies; Fractures of the tarsals, metatarsals and other fractures of the foot; Avulsion fractures and fractures of metatarsal V; Tarso-metatarsal and metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures, Subtalar arthrodesis. Ankle arthrodesis. Fractures of small joints, such as: Ankle fractures, Navicular fractures, Fractures of the fibula, malleolus, and calcaneus.

The Intraosseous Fusion Device System is not intended for spinal use.

Device Description

The Intraosseous Fusion Device (IFD) is a threaded titanium implant that is designed to provide stabilization of bones, bone segments or bone fragments to facilitate arthrodesis. The implant has an interrupted external thread to facilitate placement and fixation. The implant is hollow, which allows packing of bone graft material, and fenestrated, which allows bone growth and formation throughout the implant. The implants come in a variety of diameters (6, 9, 12mm) and lengths (10, 15 & 20mm) to address different anatomy locations. The implants are made from Ti6-6Al-4V alloy. The Intraosseous Fusion Device System includes implants, the instruments necessary to implant them, and the tray system for transport, storage and sterilization. The system is provided non-sterile and requires steam sterilization at point of use. Single-use metallic implants are time stable. Reusable instruments are inspected in reprocessing for conditions compromising function. All instruments (except for k-wires) are reusable and can be reprocessed.

AI/ML Overview

The provided document is a 510(k) summary for the Auxano Medical LLC Intraosseous Fusion Device System. It is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. This type of submission does not involve clinical studies with human participants for acceptance criteria related to diagnostic performance or multi-reader multi-case studies typically seen with AI/ML devices.

The acceptance criteria and "device performance" in this context refer to engineering and biocompatibility testing against recognized standards to ensure the device is safe and effective for its intended mechanical function, rather than diagnostic accuracy.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Test Standard/Type)	Reported Device Performance (Summary)
Mechanical Testing (ASTM F543):	The device underwent torsional strength, driving torque, and axial pullout strength testing per ASTM F543. Performance demonstrated substantial equivalence to the additional predicate device (OrthoSolutions System26 Bone Screws).
Mechanical Testing (ASTM F2077):	The device underwent static and cyclic radial compression testing per ASTM F2077.
Implant Cleanliness Validation:	Validation was carried out at the implant vendor (Marle Tangible) and internally following subsequent shipping, inspection, and warehouse tasks.
Biocompatibility (Cytotoxicity):	GLP (Good Laboratory Practice) cytotoxicity testing was conducted on the IFD implants and instruments. (Implied to meet acceptable levels, as no concerns were raised).
Sterilization Validation:	Steam sterilization validation testing was conducted on the IFD system according to ISO 17665-1 and ISO 14937 to achieve a Sterility Assurance Level (SAL) of 10-6 (as devices are provided non-sterile and require steam sterilization at the point of use).
Manual Cleaning Validation:	Manual cleaning validation testing was conducted on the worst-case instrument following simulated use cycles according to AAMI TIR12 and AAMI TIR30. (Implied to be effective).
Shipping Simulation:	Shipping simulation was conducted on the IFD system and packaging according to ISTA 3A. (Implied that the device and packaging maintained integrity).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes engineering bench testing, not clinical studies with human test subjects. Therefore, traditional "sample size" for a test set (e.g., number of patients or images) and "data provenance" (country, retrospective/prospective) as understood for diagnostic device performance are not applicable here. The "sample size" would refer to the number of devices or components tested in each mechanical or validation test, which is not specified in this summary but would be detailed in the full test reports.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The device is a physical intraosseous fusion device, not a diagnostic imaging or AI system requiring expert interpretation as ground truth for a test set. Ground truth is established through adherence to recognized engineering standards and biocompatibility tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no diagnostic test set requiring human adjudication.

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

This is not applicable. This device is a medical implant, not an AI/ML diagnostic software, and therefore MRMC studies are not performed for its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by:

Adherence to recognized international and national standards: e.g., ASTM F543, ASTM F2077 for mechanical properties; ISO 17665-1, ISO 14937 for sterilization; AAMI TIR12, AAMI TIR30 for cleaning; ISTA 3A for shipping.
Biocompatibility testing: GLP cytotoxicity testing.
Material specifications: Ti-6Al-4V (ASTM F136 & F3001).

These standards and tests define what constitutes acceptable performance and safety for such a device.

8. The sample size for the training set

This is not applicable as there is no AI/ML component or "training set" in the context of this physical medical device.

9. How the ground truth for the training set was established

This is not applicable as there is no AI/ML component or "training set" in the context of this physical medical device.

Summary

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September 29, 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Auxano Medical LLC James Price Senior Design Engineer 8006 Katherine Blvd. Brecksville, Ohio 44141

Re: K231649

Trade/Device Name: Intraosseous Fusion Device System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 21, 2023 Received: August 21, 2023

Dear Mr. Price:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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Indications for Use

510(k) Number (if known) K231649

Device Name Intraosseous Fusion Device System

Indications for Use (Describe)

Minimally invasive reconstruction of fractures and joints; Fractures of the foot and ankle; Osteochrondritis dissecans, Ostero-Chondral Fractures, Other small fragment, cancellous bone fractures, Small joint fusion. Metatarsal and phalangeal osteotomies: Fractures of the tarsals and other fractures of the foot: Avulsion fractures and fractures of metatarsal V; Tarso-metatarsal and metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures, Subtalar arthrodesis. Ankle arthrodesis. Fractures of small joints, such as: Ankle fractures, Fractures of the fibula, malleolus, and calcaneus.

The Intraosseous Fusion Device System is not intended for spinal use.

Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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K231649 Page 1 of 6

510(k) Summary

Intraosseous Fusion Device System

SUBMITTER

Auxano Medical LLC 8006 Katherine Boulevard Brecksville, OH 44141 Phone: 440-262-2000

Contact Person: James Price - Senior Design Engineer Email: James.Price@auxanomedical.net Date Prepared: August 28, 2023

DEVICE INFORMATION

Trade/Device Name: Intraosseous Fusion Device System Common Name: Intraosseous Fusion Device System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC

PREDICATE INFORMATION

Predicate Device: K191995 (S4 Screw System; Subchondral Solutions, Inc.) Additional Predicate Device: K163489 (OrthoSolutions 'System26' Bone Screws; Ortho Solutions UK Limited)

INDICATIONS FOR USE:

Minimally invasive reconstruction of fractures and joints; Fractures of the foot and ankle; Osteochrondritis dissecans, Ostero-Chondral Fractures, Other small fragment, cancellous bone fractures, Small joint fusion. Metatarsal and phalangeal osteotomies; Fractures of the tarsals, metatarsals and other fractures of the foot; Avulsion fractures of metatarsal V; Tarsometatarsal and metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures, Subtalar arthrodesis. Ankle arthrodesis. Fractures of small joints, such as: Ankle fractures, Navicular fractures, Fractures of the fibula, malleolus, and calcaneus.

The Intraosseous Fusion Device System is not intended for spinal use.

DEVICE DESCRIPTION

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requires steam sterilization at point of use. Single-use metallic implants are time stable. Reusable instruments are inspected in reprocessing for conditions compromising function. All instruments (except for k-wires) are reusable and can be reprocessed.

Image /page/4/Figure/2 description: The image shows a cylindrical object with a complex, repeating pattern on its outer surface. The object appears to be hollow, with a smooth inner surface and several circular holes distributed along its length. The outer surface is covered in a grid-like arrangement of raised, rectangular blocks, creating a textured and segmented appearance. The object is rendered in a neutral gray color, giving it a metallic or industrial look.

Figure 1. Intraosseous Fusion Device

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATES:

Table 1.

	Subject Device:Auxano Medical- IntraosseousFusion Device System	Predicate (K191995):Subchondral Solutions- S4 Screw	Additional Predicate (K163489):OrthoSolutions- System26 Bone Screws
Device Classand ProductCode:	Class II; HWC	Class II; HWC	Class II; HWC & HTN
	Substantial Equivalence:	Same	Similar
Sterilization:	Implants & Instruments- providedNON-STERILE; Steam sterilize on-siteto SAL of 10-6	Implant & Instruments- provided STERILE	Implants & Instruments- provided NON-STERILE
	Substantial Equivalence:	Different	Similar
Prescription:	Prescription Only	Prescription Only	Prescription Only
	Substantial Equivalence:	Same	Same
Indications forUse:	The Intraosseous Fusion Device System isindicated for use in skeletally matureindividuals for fracture repair andarthrodesis, osteotomy, joint fusion andfragment fixation appropriate with the sizeof the implant including:Minimally invasive reconstruction offractures and joints; Fractures of the footand ankle; Osteochrondritis dissecans,Ostero-Chondral Fractures, Other smallfragment, cancellous bone fractures, Smalljoint fusion. Metatarsal and phalangealosteotomies; Fractures of the tarsals,metatarsals and other fractures of the foot;Avulsion fractures and fractures ofmetatarsal V; Tarso-metatarsal andmetatarso-phalangeal arthrodesis; Tarsal	Minimally invasive reconstruction of fractures and joints;Adjuvant for osteosynthesis in complex joint fractures;Multifragment joint fractures; Simple metaphyseal fractures,Fractures of the wrist, ankle, elbow, and shoulder, Condylarfractures: Osteochrondritis dissecans, OsteochondralFractures, Ligament avulsion injuries, Ligament fixation,Other small fragment, cancellous bone fractures, Small jointfusion. Areas where accurate screw placement is vital.Metatarsal and phalangeal osteotomies; Fractures of thetarsals, metatarsals and other fractures of the foot; Avulsionfractures and fractures of metatarsal V; Tarso-metatarsal andmetatarsophalangeal arthrodesis; Tarsal Fusions; Calcanealand talar fractures, Subtalar arthrodesis, Ankle arthrodesis.Fractures of small joints, such as: Ankle fractures, Navicularfractures, Fractures of the fibula, malleolus, and calcaneus,Distal tibia and pilon fractures, Acetabular fractures. Otherfractures of the pelvic ring; Fractures of the femoral head and	The OrthoSolutions 'System26' cannulated screws (headed andheadless compression) and washers are indicated for use over aguide pin or wire for aligned bone fracture repair and arthrodesis,osteotomy, joint fusion and bone fragment fixation appropriate withthe size of the screw. Washers of matching size to the headedcannulated bone screw may be used in certain applications fordeficient osteopenic bone. The non-cannulated 2.0 (headed, headlesscompression and Twist-Off) bone screws are applicable, as well, forbone fracture repair and arthrodesis, osteotomy, joint fusion andbone fragment fixation appropriate with the size of the screw.'System26' non-cannulated 2.0mm (headed, headless compressionand Twist-Off) bone screws and cannulated (headed and headlesscompression) bone screw sizes of 2.0mm, 2.5mm 3.0mm areindicated for treating small bone fractures as well as performingosteotomies, arthrodesis and joining cancellous bone fragments inthe upper and lower limb and extremities.
	Subject Device:Auxano Medical- IntraosseousFusion Device System	Predicate (K191995):Subchondral Solutions- S4 Screw	Additional Predicate (K163489):OrthoSolutions- System26 Bone Screws
	Fusions; Calcaneal and talar fractures,Subtalar arthrodesis. Ankle arthrodesis.Fractures of small joints, such as: Anklefractures, Navicular fractures, Fractures ofthe fibula, malleolus, and calcaneus.The Intraosseous Fusion Device System isnot intended for spinal use.	neck, Supracondylar femoral fractures, Slipped capitalfemoral epiphyses, An adjunct to DHIS in basilar neckfractures, Intercondylar femur fractures, Intracapsularfractures of the hip, Fractures of the distal femur and proximaltibia, Patellar fractures, Tibial plateau fractures. Smallfragments of the hand and wrist, Fractures of the carpals andmetacarpals, Carnal and metacarpal arthrodesis, Scaphoidfracture and other fractures of the hand, Phalangeal andinterphalangeal fractures, Fractures of the ulna and radius.Radial head fractures, Fractures of the olecranon and distalhumerus, Humeral head fractures, Ligament fixation at theproximal humerus, Glenoid fractures.	'System26' cannulated bone screw sizes (headless compression andheaded with optional matching washer) of 4.0mm, 5.0mm, 6.5mm,and 8.0mm are indicated to be used with large and long bones.Specific indications, which are dependent in part on the diameter ofthe screw include: Minimally invasive bone fracture/jointreconstructions; Additive osteosynthesis for complex joint fractures;Multiple-fragment joint fractures; Femoral neck and femoral headfractures; Femoral supracondylar fractures; Tibial plateau fractures;Fractures of the head of the humerus; Fractures of the tibia; Cooperfractures of the tibia; Bone fractures of the radius, wrist, ankle,elbow, and shoulder; Ligament fixation of the proximal humerus;Bone fractures of the acetabulum and dorsal pelvic ring; Condylarfractures; Ligament avulsion injuries; Malleolar and navicularfractures; Bone fractures of the calcaneus and talus; Arthrodesis ofthe ankle joint; Arthrodesis of foot joints and; Avulsion fractures.The OrthoSolutions 'System26' Bone Screws are not intended forspinal use.
	Substantial Equivalence:	Similar	Similar
Intended Use:	Bone fixation of fractures, fusions(arthrodesis), osteotomies andfragments.	Bone fixation of fractures, fusions (arthrodesis) andosteotomies.	Bone fixation of fractures, fusions (arthrodesis), osteotomies andfragments.
	Substantial Equivalence:	Similar	Same
Components:	K-wires, sizers, drills, taps, drivers,driver handles	K-wires, countersink, depth gauge, reamer, driver	K-wires, drill guides, drills, countersinks, depth gauges, drivers,driver handles, forceps, clamps, easy-outs
	Substantial Equivalence:	Similar	Similar

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	Subject Device:Auxano Medical- IntraosseousFusion Device System	Predicate (K191995):Subchondral Solutions- S4 Screw	Additional Predicate (K163489):OrthoSolutions- System26 Bone Screws
TechnicalCharacteristics:	ThreadedCannulatedHeadlessFenestratedInterrupted thread	ThreadedCannulatedHeadlessFenestratedInterrupted threadHA-coated	ThreadedCannulated and Non-cannulatedHeaded and Headless (Smooth/Threaded)
	Substantial Equivalence:	Similar	Similar
Materials:	Ti-6Al-4V (ASTM F136 & F3001)	Ti-6Al-4V (ASTM F136)(w/HA coating)	Ti-6Al-4V (ASTM F136)
	Substantial Equivalence:	Similar	Same

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PERFORMANCE DATA:

. Mechanical testing (torsional strength, driving torque, axial pullout strength) was carried out per ASTM F543 on the subject device and additional predicate, OrthoSolutions System26 bone screws.
Mechanical testing was carried out per ASTM F2077 on subject device for static and cyclic radial compression.
. Implant cleanliness validation was carried out at implant vendor (Marle Tangible) and internally following subsequent shipping, inspection and warehouse tasks.
. GLP cytotoxicity testing was conducted on the IFD implants and instruments.
. Steam sterilization validation testing was conducted on the IFD system according to ISO 17665-1 and ISO 14937.
. Manual cleaning validation testing was conducted on the worst-case instrument following simulated use cycles according to AAMI TIR12 and AAMI TIR30.
Shipping simulation was conducted on the IFD system and packaging according to ISTA 3A.

CONCLUSION

The subject Intraosseous Fusion Device System has same intended use and similar indications for use, the similar technology, comparable principles of operation, and similar materials as the identified predicate systems: Subchondral Solutions- S4 Screw (K191995) and OrthoSolutions-System26 Bone Screws (K163489). The IFD System does not raise any new questions of safety or effectiveness as compared to the predicate systems. Performance testing according to ASTM F543 demonstrates substantially equivalent mechanical performance of the subject device as compared to the System26 Bone screws currently on the market. Therefore, the Intraosseous Fusion Device System is substantially equivalent to the identified predicate systems.

Regulation Number and Section

§ 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.