FuzeFix Screw System
Device Facts
| Record ID | K170038 |
|---|---|
| Device Name | FuzeFix Screw System |
| Applicant | Fusion Orthopedics, LLC |
| Product Code | HWC · Orthopedic |
| Decision Date | Aug 7, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
FuzeFix Screw System comprises headed/headless, partial/full threaded, cannulated, self-compressive, and snap-off screws with washers. Used for orthopedic osteotomies and trauma management in hand, foot, wrist, and ankle. Screws are self-drilling and self-tapping. System includes various lengths/diameters and associated surgical instruments. Operated by orthopedic surgeons in clinical/OR settings. Implants provide mechanical stabilization of bone fragments to facilitate healing. No software or electronic components.
Clinical Evidence
No clinical studies were performed. Bench testing only: Torque to failure, axial pullout strength, and insertion/removal torque (ASTM F543-07). Pyrogenicity evaluated via LAL assay (endotoxin < 20 EU/device).
Technological Characteristics
Materials: Titanium alloy Ti-6Al-4V (ASTM F136). Geometry: Headed/headless, cannulated, self-drilling/self-tapping screws. Dimensions: Ø2-7.3 mm, length 8-130 mm. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.
Indications for Use
Indicated for stabilization/fixation of bone fractures, osteotomies, non-unions, reconstruction, tendon reattachment, and arthrodesis in hand, foot, wrist, and ankle. Specific indications include various fractures (scaphoid, metacarpal, phalangeal, ulnar, humeral, patellar, metatarsal, radial, malleolar, etc.), joint fusions, and osteochondral fragments. Contraindicated for use in the spine.
Regulatory Classification
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.
Predicate Devices
- Osteomed ExtremiFix Cannulated Screw System (K063298 / K151021)
- CHARLOTTE™ Snap-Off Screw (K043583)
- Cannulated Bone Screws, OrthoPro, LLC (K042310)
- Tiger Cannulated Screw System (K081510)
- Synthes Cannulated Screws (K963172 / K021932)
- Acutrak® 2 Screw System (K944330)
- Arthrex Compression FT Screws (K132217)
Reference Devices
Submission Summary (Full Text)
{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 ( <i>Select one or both, as applicable</i> ) | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <div><span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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 16 | May 16, 2017 | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------|
| Submitted By | Fusion Orthopedics, LLC<br>4135 S. Power Rd., Suite 110<br>Mesa, AZ 85212<br>800-403-6876 | | | |
| Contact | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 Tele<br>e-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 Predicate<br>Devices | CHARLOTTE™ Snap-Off Screw, Wright Medical (K043583)<br>Cannulated Bone Screws, OrthoPro, LLC (K042310)<br>Tiger Cannulated Screw System, Trilliant Surgical (K081510)<br>Synthes Cannulated Screws, Synthes (K963172 / K021932)<br>Acutrak® 2 Screw System, Acumed (K944330)<br>Arthrex Compression FT Screws, Arthrex (K132217) | | | |
| Reference Predicate<br>Devices | Kangli Pedicle Screw System, Suzhou Kangli Orthopaedics Instrument Co., Ltd (K140053 /<br>K142290) | | | |
| Device Description | The FuzeFix Screw System consists of headed and headless, partial and full threaded<br>cannulated, self-compressive screws and snap off screws and washers for the management<br>of orthopedic osteotomies and trauma. The screws are self-drilling, self-tapping. The system<br>consists of multiple screw lengths and diameters, and the necessary instruments to facilitate<br>the placement of these implants. | | | |
| Materials | Titanium alloy, Ti-6Al-4V (ASTM F136) | | | |
| Substantial Equivalence<br>Claimed to Predicate<br>Devices | The FuzeFix Screw System is substantially equivalent to the predicate devices in terms of<br>intended 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,<br>osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the<br>hand, foot, wrist, and ankle. The FuzeFix Mini System is indicated for:<br>Scaphoid fractures, capitate fractures, metacarpal fractures, phalangeal fractures, ulnar<br>styloid fractures, small joint fusions, humeral head fractures, intercarpal fractures, tarsal<br>fusions, patellar fractures, interfragmentary ulnar fractures, small hand and wrist bone<br>fractures, forefoot interfragmentary fractures, lunate fractures, trapezial fractures, metatarsal<br>fractures, radial head fractures, osteo-chondral fractures, glenoid fractures, interphalangeal<br>fractures, malleolar fractures, metaphyseal fractures, interfragmentary radius fractures, distal<br>metatarsal osteotomies, midfoot interfragmentary fractures.<br>Not intended for use in the spine | | | |
| | | FuzeFix Mini Screw System | Instratek Mini<br>Cannulated Titanium<br>Headed and Headless<br>Screw Set | Osteomed ExtremiFix<br>Cannulated Screw<br>System |
| Indications for Use | The FuzeFix Large System is intended for use in the stabilization and fixation of bone<br>fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and<br>arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Large System is indicated for:<br>Bone reconstructions, joint fusions, multiple fragment joint fractures, simple metaphyseal<br>fractures, fractures of the wrist, ankle, elbow, and shoulder, metatarsal fractures and other<br>fractures of the foot, ligament fixation of the proximal humerus, malleolar fractures, navicular<br>fractures, fractures of the calcaneus, fractures of the talus, arthrodesis of the ankle joint, and<br>fractures of the tarsal region.<br>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<br>bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and<br>arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Headless FT System is<br>indicated for: | | | |
| | Osteochondral fragments (talar vault, femoral condyle), apical fragments (radial head,<br>patellar rim, navicular, metacarpal/metatarsal), cancellous fragments (talus), carpal,<br>meta-carpal, and small hand bone, tarsal and metatarsals, phalanges, Intra-articular<br>fractures, ankle, proximal and distal humerus, proximal and distal radius, proximal and distal<br>ulna, osteochondral fixation and fractures, osteochondritis dissecans, Fixation of fractures<br>and osteotomies about the knee, oblique fractures of the fibula, reconstructive surgeries of<br>the foot, and malleolar fixation.<br>Not intended for use in the spine. | | | |
| | The FuzeFix Twist Off System is intended for use in the stabilization and fixation of bone<br>fractures, osteotomies, and for bone reconstruction of the hand and foot. The FuzeFix Twist<br>Off System is indicated for: fixation of small bone fragments, Weil osteotomy, mono-cortical<br>fixation, osteotomies and fractures fixation in the foot and hand. | | | |
| Technological<br>Characteristics | Intended use | Fixation of fractures of bones<br>in foot, hand, wrist, & ankle | same | same |
| | Geometry | Headed/headless distal<br>thread | same | same |
| | Material | Ti-6Al-4V alloy | same | same |
| | Sizes | Ø2-4 mm, length 8-50 mm | Included in FuzeFix<br>range | Included in FuzeFix<br>range |
| | | FuzeFix Mini Screw System | OrthoPro Cannulated<br>Bone Screw | Trilliant Tiger<br>Cannulated Screw<br>System |
| | Intended use | Fixation of fractures of bones<br>in foot, hand, wrist, & ankle | same | same |
| | Geometry | Headed/headless distal<br>thread | same | same |
| | Material | Ti-6Al-4V alloy | same | same |
| | Sizes | Ø2-4 mm, length 8-50 mm | Included in FuzeFix<br>range | Included in FuzeFix<br>range |
| | FuzeFix Large Screw<br>System | Osteomed ExtremiFix<br>Cannulated Screw<br>System | Synthes Cannulated<br>Screws | |
| Intended use | Fixation of fractures of bones<br>in 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 mm<br>length 20-130 mm | Ø4.5-8.0 mm<br>length 12-140 mm | Included in FuzeFix<br>range | |
| | FuzeFix Headless Screw<br>System | Acumed Acutrak® 2<br>Screw System | Arthrex Compression<br>FT Screws | |
| Intended use | Fixation of fractures of bones<br>in foot, hand, wrist, & ankle | same | same | |
| Geometry | Headless, fully threaded | same | same | |
| Material | Ti-6Al-4V alloy | same | same | |
| | | FuzeFix Twist Off Screw<br>System | Wright<br>CHARLOTTE™ Snap-<br>Off Screw | |
| | Intended use | Fixation of fractures of bones<br>in foot & hand | same | same |
| | Geometry | Drive shaft section snaps off<br>after insertion<br>Headed, fully threaded | same | same |
| | Material | Ti-6Al-4V alloy | same | same |
| | Sizes | Ø2.0-2.5 mm<br>length 10-22 mm | Ø2.0-2.7 mm<br>length 11-15 mm | |
| The FuzeFix Screw System's technological characteristics are similar to the predicate devices. Any<br>differences do not affect the equivalency. | | | | |
| Non-clinical Test<br>Summary | The following tests were conducted:<br>• Torque to Failure (ASTM F543-07 Annex A1)<br>• Axial Pullout Strength (ASTM F543-07 Annex A2)<br>• Driving/Insertion and Removal Torque (ASTM F543-07 Annex A3)<br>• Engineering analyses<br>• Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay. The<br>testing demonstrated that the subject device meets the recommended maximum<br>endotoxin level of 20 EU per device.<br>The results of these evaluations indicate that the FuzeFix Screw System is equivalent to<br>predicate devices. | | | |
| Clinical Test Summary | No clinical studies were performed | | | |
| Conclusions: Non-<br>clinical and Clinical | Fusion Orthopedics, LLC considers the FuzeFix Screw System to be equivalent to the<br>predicate devices listed above. This conclusion is based upon the devices' similarities in<br>principles of operation, technology, materials and indications for use | | | |
{5}------------------------------------------------
{6}------------------------------------------------
# K170038 PAGE 3 OF 3
