X-BOLT Hip Fracture Fixation System

K181640 · X-Bolt Orthopaedics · HSB · Oct 12, 2018 · Orthopedic

Device Facts

• Record ID: K181640
• Device Name: X-BOLT Hip Fracture Fixation System
• Applicant: X-Bolt Orthopaedics
• Product Code: HSB · Orthopedic
• Decision Date: Oct 12, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The X-BOLT® IM Hip Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The X-BOLT® IM Hip Nailing System is indicated for use in: - Intertrochanteric and subtrochanteric fractures - Segmental fractures - Comminuted fractures - Pathological fractures - Fractures with bone loss - Pseudoarthrosis, non-union, mal-union, and delayed union - Surgically created defects such as osteotomies The X-BOLT® Dynamic Hip Plating System is intended for use in fracture fixation in the proximal femur in adults with osteopenia or osteoporosis. The X-BOLT® Dynamic Hip Plating System is indicated for use in: - Intracapsular and extracapsular fractures of the femoral neck - Trochanteric fractures of the proximal femur - Stable subtrochanteric fractures of the proximal femur

Device Story

X-BOLT® Hip Fracture Fixation System provides mechanical stabilization for femoral fractures; utilizes expanding hip bolt with four wings that deploy into premade cavities to resist cut-out; system includes IM Hip Nailing System or Dynamic Hip Plating System; components include metal nails/plates, expanding bolts, end-caps, set screws, and cortical/locking screws; used by orthopedic surgeons in clinical settings; device provides rigid fixation to support bone healing; benefits patients by reducing risk of implant cut-out in osteopenic/osteoporotic bone.

Clinical Evidence

Bench testing only. Testing included ASTM F1264-03:2012 (intramedullary devices), ASTM F384-06:2006 (angled devices), ISO 7206-04:2002 (endurance), and ASTM F543-07 (bone screws). Additional evaluations included cadaver testing for post-implantation femoral head strength, cut-out strength, and simulated expansion testing. Biocompatibility was confirmed per ISO 10993 (parts 3, 5, 6, 10, 11).

Technological Characteristics

Implant grade stainless steel with Parylene-C coating. Fixation achieved via four expanding wings. Sterilized via irradiation. Dimensions: Bolt lengths 80-125mm; Plate configurations 2-6 holes; Cortical screws 4.5mm diameter. No software or electronic components.

Indications for Use

Indicated for adult patients with osteopenia or osteoporosis requiring fracture fixation of the femur (IM Nailing System) or proximal femur (Dynamic Hip Plating System), including intertrochanteric, subtrochanteric, femoral neck, segmental, comminuted, and pathological fractures, as well as non-union, mal-union, pseudoarthrosis, and osteotomies.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Zimmer Natural Nail System (K083497, K091566, K120715)
• Smith & Nephew Asian Intramedullary Hip Screw Nails [IMHS] (K050226)
• Smith & Nephew Compression Hip Screw System (K993289, K921786, K895241)
• Stryker Howmedica Osteonics Omega 3 System (K062066)
• PERI-LOC Proximal Femur Locking Bone Plate System (K072818)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 12, 2018

X-Bolt® Orthopaedics Dr. Brian Thornes Founder & CEO Unit 5. Northwood Court Dublin, IE

Re: K181640

Trade/Device Name: X-BOLT® Hip Fracture Fixation System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, KTT Dated: June 21, 2018 Received: June 21, 2018

# Dear Dr. Brian Thornes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Daniel S. Ramsey -S 2018.10.12 15:54:43 -04'00'

For 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) K181640

Device Name

X-BOLT® Hip Fracture Fixation System

#### Indications for Use (Describe)

The X-BOLT® IM Hip Nailing System is intended for use in fracture fixation in adults with osteopenia or osteoporosis. The X-BOLT® IM Hip Nailing System is indicated for use in:

- · Intertrochanteric and subtrochanteric fractures
- Segmental fractures
- · Comminuted fractures
- · Pathological fractures
- Fractures with bone loss
- · Pseudoarthrosis, non-union, mal-union, and delayed union
- · Surgically created defects such as osteotomies

The X-BOLT® Dynamic Hip Plating System is intended for use in fracture fixation in the proximal femur in adults with osteopenia or osteoporosis. The X-BOLT® Dynamic Hip Plating System is indicated for use in:

- · Intracapsular and extracapsular fractures of the femoral neck
- · Trochanteric fractures of the proximal femur
- · Stable subtrochanteric fractures of the proximal femur

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

{3}------------------------------------------------

# 510(k) Summary for X-BOLT® Hip Fracture Fixation System

#### 1. Submission Sponsor

X-BOLT® Orthopaedics Unit 5 Northwood Court Santry, Dublin 9 Ireland Phone: [phone]

Contact: Brian Thornes, MCh FRCSI MBA Founder & CEO Email: [e-mail]

#### 2. Prepared by

Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street, NW, Suite 1000 Washington, DC 20001 Phone: [phone]

Contact: Ms. Hollace Saas Rhodes Senior Director, Orthopedic Regulatory Affairs Email: [e-mail]

#### 3. Date Prepared

October 3, 2018

#### 4. Device Name

| Trade/Proprietary Name: | X-BOLT® Hip Fracture Fixation System |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Trochanteric Nail and Dynamic Hip Plating System |
| Classification Name: | Intramedullary fixation rod; Appliance, Fixation, Nail/Blade/Plate<br>Combination, Multiple Component, Single/Multiple Component<br>Metallic bone fixation appliances and accessories. |
| Classification Regulation: | 21 CFR 888.3020 and 21 CFR 888.3030 |
| Classification Panel: | Orthopedics |
| Product Code: | HSB, KTT |
| Device Class: | II |

#### 5. Predicate and Reference Devices

The X-BOLT® Hip Fracture Fixation System is substantially equivalent to the Zimmer Natural Nail System (K083497, K091566, K120715), Smith & Nephew Asian Intramedullary Hip Screw Nails [IMHS] (K050226), Smith & Nephew Compression Hip Screw System (K993289, K921786, and K895241), and Stryker Howmedica Osteonics Omega 3 System (K062066) based on similarities in intended use, technological characteristics, and performance data. The PERI-LOC Proximal Femur

{4}------------------------------------------------

Locking Bone Plate System (K072818) serves as a predicate device based on similar technological characteristics and the same intended use.

#### 6. Device Description

#### IM Hip Nailing System

The X-BOLT® IM Hip Nailing System is a single use device intended for long-term (greater than 30 days) implantation into the femur. The X-BOLT® IM Hip Nailing System consists of the following components.

A. X-BOLT®: The X-BOLT® is an expanding hip bolt available in various sizes.

B. X-BOLT® IM Hip Nail: The X-BOLT® IM Hip Nail is a metal nail which is designed to be used in conjunction with the X-BOLT® to provide fixation of fractures of the femur. It is available in various lengths, in right and left configurations.

C. End-Cap: End-Caps prevent bone ingrowth into the proximal end of the nail.

D. Set Screw: The set screw prevents the X-BOLT® from rotating, while still allowing for dynamic movement.

E. X-BOLT® Distal Locking Screws: The X-BOLT® Distal Locking Screws are bone fixation screws which are designed to be used in conjunction with the X-BOLT® IM Hip Nail to achieve distal fixation of the nail. The X-BOLT® Distal Locking Screws are available in various lengths.

#### Dynamic Hip Plating System

The X-BOLT® Dynamic Hip Plating System is a single use device intended for long-term (greater than 30 days) implantation into the proximal femur. The X-BOLT® Dynamic Hip Plating System consists of the following components.

A. X-BOLT®: The X-BOLT® is an expanding hip bolt available in various sizes.

B. X-BOLT® Dynamic Hip Plate: The X-BOLT® Dynamic Hip Plate is an angled metal plate which is designed to be used in conjunction with the X-BOLT® to provide fixation of fractures of the proximal femur. It is available in various sizes.

C. X-BOLT® Cortical Screws: The X-BOLT® Cortical Screws are bone fixation screws which are designed to be used in conjunction with the X-BOLT® Dynamic Hip Plate to provide fixation of fractures of the proximal femur. The X-BOLT® Cortical Screws are available in various lengths.

#### 7. Intended Use

#### IM Hip Nailing System

The X-BOLT® IM Hip Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The X-BOLT® IM Hip Nailing System is indicated for use in:

- Intertrochanteric and subtrochanteric fractures
- Segmental fractures

{5}------------------------------------------------

- Comminuted fractures
- Pathological fractures
- Fractures with bone loss
- Pseudoarthrosis, non-union, mal-union, and delayed union
- Surgically created defects such as osteotomies

#### Dynamic Hip Plating System

The X-BOLT® Dynamic Hip Plating System is intended for use in fracture fixation in the proximal femur in adults with osteopenia or osteoporosis.

The X-BOLT® Dynamic Hip Plating System is indicated for use in:

- Intracapsular and extracapsular fractures of the femoral neck
- Trochanteric fractures of the proximal femur
- Stable subtrochanteric fractures of the proximal femur

#### 8. Technological Characteristics and Substantial Equivalence

The following tables compares the X-BOLT® Hip Fracture Fixation system to the respective predicate devices. The table below compares the IM Hip Nailing System to the Zimmer Natural Nail System (K083497; K091566; K120715) with respect to intended use, technological characteristics and principles of operation to support a determination of substantial equivalence for the X-BOLT® device.

{6}------------------------------------------------

| Manufacturer | X-BOLT® Orthopaedics | Zimmer |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | X-BOLT® IM Hip Nailing System | Zimmer® Natural Nail™ System |
| 510(k) Number | Subject device | K083497; K091566; K120715 |
| Product Code | HSB | HSB |
| Regulation<br>Number | 21 CFR 888.3020 | 21 CFR 888.3020 |
| Classification | II | II |
| Indications for<br>use: | The X-BOLT® IM Hip Nailing System is<br>intended for use in fracture fixation in<br>the femur in the adult population. The<br>X-BOLT® IM Hip Nailing System is<br>indicated for use in:<br>• Intertrochanteric and<br>subtrochanteric fractures<br>• Segmental fractures<br>• Comminuted fractures<br>• Fractures involving osteopenic<br>and osteoporotic bone<br>• Pathological fractures<br>• Fractures with bone loss<br>• Pseudoarthrosis, non-union,<br>mal-union, and delayed union<br>• Surgically created defects such<br>as osteotomies | The Zimmer® Natural Nail™<br>System is intended for temporary<br>fixation and stabilization of the<br>bone. Indications for use of the<br>greater Trochanter and Piriformis<br>Fossa nails in the femur include:<br>• Compound and simple shaft<br>fractures<br>• Proximal, metaphyseal, and<br>distal shaft fractures<br>• Segmental fractures<br>• Comminuted fractures<br>• Fractures involving osteopenic<br>and osteoporotic bone<br>• Pathological fractures<br>• Fractures with bone loss<br>• Pseudoarthrosis, non-union,<br>mal-union, and delayed union<br>• Periprosthetic fractures<br>• Surgically created defects such<br>as osteotomies<br>• Intertrochanteric and<br>subtrochanteric fractures |
| Components<br>and Design | • Intramedullary Nail, Fixation Bolt,<br>Distal Screws<br>• Achieves fixation via four<br>expanding wings that expand<br>precisely into premade cavities<br>and are designed to resist cut-out | • Intramedullary nail, Lag Screw,<br>and Distal Screw<br>• Achieves fixation via a threaded<br>sliding lag screw |
| Materials | Implant grade stainless steel<br>Parylene C Coating | Titanium Alloy (Ti-6Al-4V) |
| Manufacturer | X-BOLT® Orthopaedics | Stryker Howmedica Osteonics |
| Trade Name | X-BOLT® Dynamic Hip Plating<br>System | Omega 3 System |
| 510(k) Number | Subject device | K062066 |
| Product Code | KTT | KTT |
| Regulation<br>Number | 21 CFR 888.3030 | 21 CFR 888.3030 |
| Classification | II | II |
| Indications for<br>use: | The X-BOLT® Dynamic Hip<br>Plating System is intended for<br>use in fracture fixation in the<br>proximal femur in the adult<br>population. The X-BOLT®<br>Dynamic Hip Plating System is<br>indicated for use in:<br>• Intracapsular and<br>extracapsular fractures of the<br>femoral neck<br>• Trochanteric fractures of the<br>proximal femur<br>• Stable subtrochanteric<br>fractures of the proximal<br>femur | The Omega (Systems) are<br>intended for use in the<br>temporary stabilization of types<br>of fractures to the proximal and<br>distal femur. The subject<br>devices are indicated for<br>fixation of proximal and distal<br>femoral fractures including but<br>not limited to:<br>• Intracapsular and basal neck<br>fractures including<br>transcervical and subcapital<br>fractures<br>• Intertrochanteric fractures<br>• Subtrochanteric fractures<br>• Supracondylar fractures<br>• Osteotomies for patients with<br>diseases or deformities of the<br>hip<br>• Hip arthrodesis |
| Components and<br>Design | • Implant grade stainless steel<br>plate, screws and fixation<br>bolt<br>• Achieves fixation via four<br>expanding wings that<br>expand precisely into<br>premade cavities and are<br>designed to resist cut-out | • Implant grade stainless steel<br>plate, screws and lag screw<br>• Achieves fixation via a<br>threaded sliding lag screw |
| Materials | Implant grade stainless steel<br>Parylene-C coating | Implant grade stainless steel |
| Sterility | Sterile (irradiation) | Sterile |
| Manufacturer | X-BOLT® Orthopaedics | Stryker Howmedica Osteonics |
| Trade Name | X-BOLT® Dynamic Hip Plating<br>System | Omega 3 System |
| Dimensions | The X-BOLT® is an expanding<br>hip bolt available in 10<br>different lengths ranging<br>from 80mm to 125mm in<br>5mm increments. | The Omega 3 bolt is available in<br>various sizes ranging from<br>50mm to 140 mm in 5mm<br>increments |
| | The X-BOLT® Dynamic Hip<br>Plate is a 135° angled metal<br>plate and is available in four<br>different sizes - 2-hole,<br>4- hole, 5-hole and 6-hole<br>configurations. | The Omega 3 system plate is<br>available in keyed and keyless<br>configurations, in short and<br>standard barrel options,<br>ranging from 2 hole to 12<br>holes, with multiple options<br>for plate angles (130 – 150°)<br>and in lengths from 47 –<br>207mm. |
| | X-BOLT® Cortical Screws are<br>4.5mm in diameter and<br>available in 10 different sizes<br>from 30mm to 48mm in 2mm<br>increments | Omega cortical screws are<br>4.5mm in diameter and<br>available in 14-110 mm in 2-<br>5mm increments. Other<br>locking screws also offered (14-<br>95mm). |

## Comparison Table: X-BOLT® IM Hip Nailing System vs. Zimmer Natural Nail System

The table below compares the X-BOLT® Dynamic Hip Plating System to the Stryker Howmedica Osteonics Omega 3 System (K062066) with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

{7}------------------------------------------------

# Comparison Table: X-BOLT® Dynamic Hip Plate vs. Stryker Howmedica Osteonics Omega 3 System

{8}------------------------------------------------

#### 9. Performance Testing

The X-BOLT® Hip Fracture Fixation System underwent the following testing which supports its substantial equivalence to predicate devices:

- . ASTM F1264-03:2012 – Standard specification and test methods for intramedullary fixation devices.
- . ASTM F384-06:2006 - Standard specifications and test methods for metallic angled orthopedic fracture fixation devices.
- . ISO 7206-04:2002 –Partial and Total Hip Joint Prostheses – Part 4: Determination of Endurance Properties of Stemmed Femoral Components.
- . ASTM F543-07 – Standard specification and test methods for metallic medical bone screws.
- . Cadaver testing to evaluate the post-implantation strength of the femoral head
- Cut-out strength of device from femoral head
- Simulated expansion testing of the X-Bolt device
- . Pyrogen LAL testing

The results of all testing of the X-BOLT® Hip Fracture Fixation System demonstrate that it performs comparably to predicate devices, thereby supporting its substantial equivalence.

{9}------------------------------------------------

#### 10. Biocompatibility Testing

The X-BOLT® Hip Fracture Fixation System was tested in accordance with ISO 10993 to demonstrate its biocompatibility.

- . Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
- . Part 5: Tests for in vitro cytotoxicity
- . Part 6: Tests for local effects after implantation
- . Part 10: Tests for irritation and delayed-type hypersensitivity
- Part 11: Tests for Systemic Toxicity

### 11. Conclusion

This 510(k) submission demonstrates the substantial equivalence of the X-BOLT® Hip Fracture Fixation System to the referenced predicate devices.