The FuzeFix Mini System is intended for use in the stabilization of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Mini System is indicated for: scaphoid fractures, metacarpal fractures, phalangeal fractures, ulnar styloid fractures, small ioint fusions, humeral head fractures, intercarpal fractures, tarsal fusions, patellar fractures, interfragmentary ulnar fractures, small hand and wrist bone fractures, forefoot interfragmentary fractures, trapezial fractures, metatarsal fractures, radial head fractures, osteo-chondral fractures, interphalangeal fractures, malleolar fractures, metaphyseal fractures, interfragmentary radius fractures, distal metatarsal osteotomies, midfoot interfragmentary fractures. Not intended for use in the spine.

The FuzeFix Large System is intended for use in the stabilization and fixation of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Large System is indicated for: joint reconstructions, joint fusions, multiple fragment joint fractures, simple metaphyseal fractures of the wrist, ankle, elbow, and shoulder, metatarsal fractures and other fractures of the foot, ligament fixation of the proximal humerus, malleolar fractures, navicular fractures of the calcaneus, fractures of the talus, arthrodesis of the ankle joint, and fractures of the tarsal region. The devices and implants are not intended for use in the spine.

The FuzeFix Headless FT System is intended for use in the stabilization and fixation of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Headless FT System is indicated for: Osteochondral fragments (talar vault, femoral condyle), apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), cancellous fragments (talus), Carpal, meta-carpal, and small hand bone, tarsal and metatarsals, phalanges, Intra-articular fractures, ankle, proximal and distal humerus, proximal and distal radius, proximal and distal ulna, osteochondral fixation and fractures, Osteochondritis Dissecans, Fixation of fractures and osteotomies about the knee, Oblique fractures of the fibula, Reconstructive surgeries of the foot, and malleolar fixation. Not intended for use in the spine.

The FuzeFix Twist Off System is intended for use in the stabilization of bone fractures. osteotomies, and for bone reconstruction of the hand and foot. The FuzeFix Twist Off System is indicated for: fixation of small bone fragments, Weil osteotomy, mono-cortical fixation, osteotomies and fractures fixation in the foot and hand.

Device Description

The FuzeFix Screw System consists of headed and headless, partial and full threaded cannulated, self-compressive screws and snap off screws and washers for the management of orthopedic osteotomies and trauma. The screws are self-drilling, self-tapping. The system consists of multiple screw lengths and diameters, and the necessary instruments to facilitate the placement of these implants.

AI/ML Overview

The provided document describes the Fusion Orthopedics, LLC FuzeFix Screw System and its substantial equivalence to predicate devices, based on non-clinical testing. It explicitly states that "No clinical studies were performed." Therefore, the information requested about acceptance criteria and studies proving the device meets them, in the context of clinical performance or AI/software, is not largely applicable or available in this document.

However, I can extract information related to the device's non-clinical performance acceptance criteria and the study that proves it meets them, as documented for regulatory submission.

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

The document does not explicitly present a table of acceptance criteria and reported device performance in terms of specific numerical values for each test. Instead, it lists the types of non-clinical tests performed and states that the "testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device" and "The results of these evaluations indicate that the FuzeFix Screw System is equivalent to predicate devices." This implies that the device met the acceptance criteria for each test by showing equivalence or compliance with established standards.

Acceptance Criteria (Implied by Test Type)	Reported Device Performance
Torque to Failure (ASTM F543-07 Annex A1)	Device performance was found to be "equivalent to predicate devices."
Axial Pullout Strength (ASTM F543-07 Annex A2)	Device performance was found to be "equivalent to predicate devices."
Driving/Insertion and Removal Torque (ASTM F543-07 Annex A3)	Device performance was found to be "equivalent to predicate devices."
Engineering analyses	Device performance was found to be "equivalent to predicate devices."
Pyrogenicity (Limulus amebocyte lysate (LAL) assay)	Meets the recommended maximum endotoxin level of 20 EU per device.

The underlying acceptance criteria for "equivalence" would be that the device's mechanical properties (torque, pullout, driving/insertion/removal torque) perform within a comparable range or demonstrate similar failure modes and strengths to the established predicate devices, as typically determined through statistical comparison or by falling within a predefined performance envelope during mechanical testing.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for each non-clinical test (e.g., number of screws tested for torque to failure). It also does not explicitly mention data provenance in terms of country of origin for these non-clinical tests, and non-clinical tests are inherently "prospective" in the context of generating new data for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The "ground truth" for non-clinical mechanical and biocompatibility testing is established by conforming to recognized industry standards (e.g., ASTM F543-07 for mechanical tests, and general biocompatibility standards for pyrogenicity). It does not involve expert readers or clinical ground truth determination.

4. Adjudication method for the test set

This question is not applicable as the tests are non-clinical, objective measurements against established standards, not subjective interpretations requiring 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

No such study was performed, as stated in the document: "No clinical studies were performed." This is not an AI/software device, but a physical medical implant.

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

This question is not applicable. This is a physical medical implant, not an AI algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is based on:

Established Industry Standards: ASTM F543-07 Annex A1, A2, and A3 for mechanical properties (torque to failure, axial pullout, driving/insertion/removal torque).
Biocompatibility Standards: Implicit standards leading to the "recommended maximum endotoxin level of 20 EU per device" for pyrogenicity.
Predicate Device Performance: The primary comparative "ground truth" for equivalence claims is the performance of the legally marketed predicate devices.

8. The sample size for the training set

This question is not applicable. There is no artificial intelligence or machine learning component mentioned that would require a training set.

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

This question is not applicable. There is no artificial intelligence or machine learning component mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

August 7, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Fusion Orthopedics, LLC % J.D. Webb Regulatory Consultant The Orthomedix Group, Inc. 1001 Oakwood Blvd. Round Rock, Texas 78681

Re: K170038

Trade/Device Name: FuzeFix 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: July 25, 2017 Received: July 28, 2017

Dear J.D. Webb:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170038

Device Name FuzeFix Screw System

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
☑ 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: FuzeFix Screw System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

May 16	May 16, 2017
Submitted By	Fusion Orthopedics, LLC4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-6876
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Telee-mail: jdwebb@orthomedix.net
Trade Name	FuzeFix Screw System
Common Name	Bone screws
Classification Name	Smooth & threaded metallic bone fixation fasteners
Class	II
Product Code	HWC
CFR Section	21 CFR section 888.3040
Device Panel	Orthopedic
Primary Predicate Device	Osteomed ExtremiFix Cannulated Screw System, Wright Medical (K063298 / K151021)
Secondary PredicateDevices	CHARLOTTE™ Snap-Off Screw, Wright Medical (K043583)Cannulated Bone Screws, OrthoPro, LLC (K042310)Tiger Cannulated Screw System, Trilliant Surgical (K081510)Synthes Cannulated Screws, Synthes (K963172 / K021932)Acutrak® 2 Screw System, Acumed (K944330)Arthrex Compression FT Screws, Arthrex (K132217)
Reference PredicateDevices	Kangli Pedicle Screw System, Suzhou Kangli Orthopaedics Instrument Co., Ltd (K140053 /K142290)
Device Description	The FuzeFix Screw System consists of headed and headless, partial and full threadedcannulated, self-compressive screws and snap off screws and washers for the managementof orthopedic osteotomies and trauma. The screws are self-drilling, self-tapping. The systemconsists of multiple screw lengths and diameters, and the necessary instruments to facilitatethe placement of these implants.
Materials	Titanium alloy, Ti-6Al-4V (ASTM F136)
Substantial EquivalenceClaimed to PredicateDevices	The FuzeFix Screw System is substantially equivalent to the predicate devices in terms ofintended use, design, materials used, mechanical safety and performances.
Indications for Use	The FuzeFix Mini System is intended for use in the stabilization and fixation of bone fractures,osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of thehand, foot, wrist, and ankle. The FuzeFix Mini System is indicated for:Scaphoid fractures, capitate fractures, metacarpal fractures, phalangeal fractures, ulnarstyloid fractures, small joint fusions, humeral head fractures, intercarpal fractures, tarsalfusions, patellar fractures, interfragmentary ulnar fractures, small hand and wrist bonefractures, forefoot interfragmentary fractures, lunate fractures, trapezial fractures, metatarsalfractures, radial head fractures, osteo-chondral fractures, glenoid fractures, interphalangealfractures, malleolar fractures, metaphyseal fractures, interfragmentary radius fractures, distalmetatarsal osteotomies, midfoot interfragmentary fractures.Not intended for use in the spine
		FuzeFix Mini Screw System	Instratek MiniCannulated TitaniumHeaded and HeadlessScrew Set	Osteomed ExtremiFixCannulated ScrewSystem
Indications for Use	The FuzeFix Large System is intended for use in the stabilization and fixation of bonefractures, osteotomies, non-unions, and reconstruction, tendon reattachment, andarthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Large System is indicated for:Bone reconstructions, joint fusions, multiple fragment joint fractures, simple metaphysealfractures, fractures of the wrist, ankle, elbow, and shoulder, metatarsal fractures and otherfractures of the foot, ligament fixation of the proximal humerus, malleolar fractures, navicularfractures, fractures of the calcaneus, fractures of the talus, arthrodesis of the ankle joint, andfractures of the tarsal region.The devices and implants are not intended for use in the spine.
	The FuzeFix Headless FT System is intended for use in the stabilization and fixation ofbone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, andarthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Headless FT System isindicated for:
	Osteochondral fragments (talar vault, femoral condyle), apical fragments (radial head,patellar rim, navicular, metacarpal/metatarsal), cancellous fragments (talus), carpal,meta-carpal, and small hand bone, tarsal and metatarsals, phalanges, Intra-articularfractures, ankle, proximal and distal humerus, proximal and distal radius, proximal and distalulna, osteochondral fixation and fractures, osteochondritis dissecans, Fixation of fracturesand osteotomies about the knee, oblique fractures of the fibula, reconstructive surgeries ofthe foot, and malleolar fixation.Not intended for use in the spine.
	The FuzeFix Twist Off System is intended for use in the stabilization and fixation of bonefractures, osteotomies, and for bone reconstruction of the hand and foot. The FuzeFix TwistOff System is indicated for: fixation of small bone fragments, Weil osteotomy, mono-corticalfixation, osteotomies and fractures fixation in the foot and hand.
TechnologicalCharacteristics	Intended use	Fixation of fractures of bonesin foot, hand, wrist, & ankle	same	same
	Geometry	Headed/headless distalthread	same	same
	Material	Ti-6Al-4V alloy	same	same
	Sizes	Ø2-4 mm, length 8-50 mm	Included in FuzeFixrange	Included in FuzeFixrange
		FuzeFix Mini Screw System	OrthoPro CannulatedBone Screw	Trilliant TigerCannulated ScrewSystem
	Intended use	Fixation of fractures of bonesin foot, hand, wrist, & ankle	same	same
	Geometry	Headed/headless distalthread	same	same
	Material	Ti-6Al-4V alloy	same	same
	Sizes	Ø2-4 mm, length 8-50 mm	Included in FuzeFixrange	Included in FuzeFixrange
	FuzeFix Large ScrewSystem	Osteomed ExtremiFixCannulated ScrewSystem	Synthes CannulatedScrews
Intended use	Fixation of fractures of bonesin foot, hand, wrist, & ankle	same	same
Geometry	Headed/headless distal thread	same	Headed, distal thread
Material	Ti-6Al-4V alloy	same	same
Sizes	Ø4.5-7.3 mmlength 20-130 mm	Ø4.5-8.0 mmlength 12-140 mm	Included in FuzeFixrange
	FuzeFix Headless ScrewSystem	Acumed Acutrak® 2Screw System	Arthrex CompressionFT Screws
Intended use	Fixation of fractures of bonesin foot, hand, wrist, & ankle	same	same
Geometry	Headless, fully threaded	same	same
Material	Ti-6Al-4V alloy	same	same
		FuzeFix Twist Off ScrewSystem	WrightCHARLOTTE™ Snap-Off Screw
	Intended use	Fixation of fractures of bonesin foot & hand	same	same
	Geometry	Drive shaft section snaps offafter insertionHeaded, fully threaded	same	same
	Material	Ti-6Al-4V alloy	same	same
	Sizes	Ø2.0-2.5 mmlength 10-22 mm	Ø2.0-2.7 mmlength 11-15 mm
The FuzeFix Screw System's technological characteristics are similar to the predicate devices. Anydifferences do not affect the equivalency.
Non-clinical TestSummary	The following tests were conducted:• Torque to Failure (ASTM F543-07 Annex A1)• Axial Pullout Strength (ASTM F543-07 Annex A2)• Driving/Insertion and Removal Torque (ASTM F543-07 Annex A3)• Engineering analyses• Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay. Thetesting demonstrated that the subject device meets the recommended maximumendotoxin level of 20 EU per device.The results of these evaluations indicate that the FuzeFix Screw System is equivalent topredicate devices.
Clinical Test Summary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Fusion Orthopedics, LLC considers the FuzeFix Screw System to be equivalent to thepredicate devices listed above. This conclusion is based upon the devices' similarities inprinciples of operation, technology, materials and indications for use

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K170038 PAGE 3 OF 3

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.