K Number
K170038
Device Name
FuzeFix Screw System
Date Cleared
2017-08-07

(214 days)

Product Code
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

No
The summary describes a system of orthopedic screws and instruments for bone fixation. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies are non-clinical mechanical tests.

Yes
The device is intended for the stabilization of bone fractures, osteotomies, non-unions, reconstruction, tendon reattachment, and arthrodesis, which are therapeutic interventions.

No

The device is a system of screws and instruments for the stabilization and fixation of bone fractures and osteotomies; it is not used for diagnosis.

No

The device description explicitly states that the system consists of "headed and headless, partial and full threaded cannulated, self-compressive screws and snap off screws and washers" and "necessary instruments to facilitate the placement of these implants," indicating it is a hardware-based medical device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for the stabilization and fixation of bone fractures, osteotomies, non-unions, reconstruction, tendon reattachment, and arthrodesis. These are all surgical procedures performed directly on the patient's body.
  • Device Description: The device is described as a system of screws and instruments used for orthopedic procedures. This is a physical implant and surgical tool, not a test or reagent used to examine specimens from the body.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.

IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used to physically stabilize bone.

N/A

Intended Use / Indications for Use

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.

Product codes

HWC

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand, foot, wrist, ankle, humeral head, patellar, tarsal, elbow, shoulder, calcaneus, talus, knee, fibula

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 Test Summary: 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. The testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device.
The results of these evaluations indicate that the FuzeFix Screw System is equivalent to predicate devices.

Clinical Test Summary: No clinical studies were performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K063298, K151021, K043583, K042310, K081510, K963172, K021932, K944330, K132217

Reference Device(s)

K140053, K142290

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

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

1

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

2

Indications for Use

510(k) Number (if known) K170038

Device Name FuzeFix Screw System

Indications for Use (Describe)

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.

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.

3

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."

4

510(k) Summary: FuzeFix Screw System

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

May 16May 16, 2017
Submitted ByFusion Orthopedics, LLC
4135 S. Power Rd., Suite 110
Mesa, AZ 85212
800-403-6876
ContactJ.D. Webb
1001 Oakwood Blvd
Round Rock, TX 78681
512-388-0199 Tele
e-mail: jdwebb@orthomedix.net
Trade NameFuzeFix Screw System
Common NameBone screws
Classification NameSmooth & threaded metallic bone fixation fasteners
ClassII
Product CodeHWC
CFR Section21 CFR section 888.3040
Device PanelOrthopedic
Primary Predicate DeviceOsteomed ExtremiFix Cannulated Screw System, Wright Medical (K063298 / K151021)
Secondary Predicate
DevicesCHARLOTTE™ 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 Predicate
DevicesKangli Pedicle Screw System, Suzhou Kangli Orthopaedics Instrument Co., Ltd (K140053 /
K142290)
Device DescriptionThe 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.
MaterialsTitanium alloy, Ti-6Al-4V (ASTM F136)
Substantial Equivalence
Claimed to Predicate
DevicesThe FuzeFix Screw System is substantially equivalent to the predicate devices in terms of
intended use, design, materials used, mechanical safety and performances.
Indications for UseThe 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 the
hand, foot, wrist, and ankle. The FuzeFix Mini System is indicated for:
Scaphoid fractures, capitate fractures, metacarpal fractures, phalangeal fractures, ulnar
styloid fractures, small joint fusions, humeral head fractures, intercarpal fractures, tarsal
fusions, patellar fractures, interfragmentary ulnar fractures, small hand and wrist bone
fractures, forefoot interfragmentary fractures, lunate fractures, trapezial fractures, metatarsal
fractures, radial head fractures, osteo-chondral fractures, glenoid fractures, interphalangeal
fractures, malleolar fractures, metaphyseal fractures, interfragmentary radius fractures, distal
metatarsal osteotomies, midfoot interfragmentary fractures.
Not intended for use in the spine
FuzeFix Mini Screw SystemInstratek Mini
Cannulated Titanium
Headed and Headless
Screw SetOsteomed ExtremiFix
Cannulated Screw
System
Indications for UseThe 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:
Bone reconstructions, joint fusions, multiple fragment joint fractures, simple metaphyseal
fractures, 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, 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 and fixation 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.
Technological
CharacteristicsIntended useFixation of fractures of bones
in foot, hand, wrist, & anklesamesame
GeometryHeaded/headless distal
threadsamesame
MaterialTi-6Al-4V alloysamesame
SizesØ2-4 mm, length 8-50 mmIncluded in FuzeFix
rangeIncluded in FuzeFix
range
FuzeFix Mini Screw SystemOrthoPro Cannulated
Bone ScrewTrilliant Tiger
Cannulated Screw
System
Intended useFixation of fractures of bones
in foot, hand, wrist, & anklesamesame
GeometryHeaded/headless distal
threadsamesame
MaterialTi-6Al-4V alloysamesame
SizesØ2-4 mm, length 8-50 mmIncluded in FuzeFix
rangeIncluded in FuzeFix
range
FuzeFix Large Screw
SystemOsteomed ExtremiFix
Cannulated Screw
SystemSynthes Cannulated
Screws
Intended useFixation of fractures of bones
in foot, hand, wrist, & anklesamesame
GeometryHeaded/headless distal threadsameHeaded, distal thread
MaterialTi-6Al-4V alloysamesame
SizesØ4.5-7.3 mm
length 20-130 mmØ4.5-8.0 mm
length 12-140 mmIncluded in FuzeFix
range
FuzeFix Headless Screw
SystemAcumed Acutrak® 2
Screw SystemArthrex Compression
FT Screws
Intended useFixation of fractures of bones
in foot, hand, wrist, & anklesamesame
GeometryHeadless, fully threadedsamesame
MaterialTi-6Al-4V alloysamesame
FuzeFix Twist Off Screw
SystemWright
CHARLOTTE™ Snap-
Off Screw
Intended useFixation of fractures of bones
in foot & handsamesame
GeometryDrive shaft section snaps off
after insertion
Headed, fully threadedsamesame
MaterialTi-6Al-4V alloysamesame
SizesØ2.0-2.5 mm
length 10-22 mmØ2.0-2.7 mm
length 11-15 mm
The FuzeFix Screw System's technological characteristics are similar to the predicate devices. Any
differences do not affect the equivalency.
Non-clinical Test
SummaryThe 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. The
testing demonstrated that the subject device meets the recommended maximum
endotoxin level of 20 EU per device.
The results of these evaluations indicate that the FuzeFix Screw System is equivalent to
predicate devices.
Clinical Test SummaryNo clinical studies were performed
Conclusions: Non-
clinical and ClinicalFusion Orthopedics, LLC considers the FuzeFix Screw System to be equivalent to the
predicate devices listed above. This conclusion is based upon the devices' similarities in
principles of operation, technology, materials and indications for use

5

6

K170038 PAGE 3 OF 3