(113 days)
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
The X-BOLT® Hip Fracture Fixation System is a single use device intended for long-term (greater than 30 days) implantation into the femur or proximal femur. The system consists of two parts: the IM Hip Nailing System and the Dynamic Hip Plating System.
IM Hip Nailing System components:
A. X-BOLT®: An expanding hip bolt.
B. X-BOLT® IM Hip Nail: A metal nail used with the X-BOLT® for femur fracture fixation.
C. End-Cap: Prevents bone ingrowth into the proximal end of the nail.
D. Set Screw: Prevents X-BOLT® rotation while allowing dynamic movement.
E. X-BOLT® Distal Locking Screws: Bone fixation screws used with the IM Hip Nail for distal fixation.
Dynamic Hip Plating System components:
A. X-BOLT®: An expanding hip bolt.
B. X-BOLT® Dynamic Hip Plate: An angled metal plate used with the X-BOLT® for proximal femur fracture fixation.
C. X-BOLT® Cortical Screws: Bone fixation screws used with the Dynamic Hip Plate for proximal femur fracture fixation.
This document is a 510(k) premarket notification for the X-BOLT® Hip Fracture Fixation System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria for AI/ML performance. Therefore, most of the requested information regarding AI/ML device testing, ground truth establishment, expert adjudication, and sample sizes for training/test sets is not available in this document.
The document describes a medical device, specifically orthopaedic implants for hip fracture fixation, not an AI/ML powered device. The "performance testing" detailed refers to biomechanical and material testing of the physical implant, not software or algorithmic performance.
However, based on the provided text, I can extract information related to the device and its testing as presented, which primarily supports its physical and material properties, rather than AI/ML performance.
Here's what can be gathered, addressing the questions to the extent possible, with many points being "Not Applicable" (N/A) or "Not Provided" due to the nature of the device and document:
1. A table of acceptance criteria and the reported device performance
The document does not present specific "acceptance criteria" in a quantitative table for device performance in the common sense of AI/ML evaluation (e.g., accuracy thresholds, sensitivity/specificity). Instead, performance is demonstrated through adherence to, and successful completion of, well-established ASTM and ISO standards for orthopedic implants. The "performance" reported is that the device "demonstrates that it performs comparably to predicate devices, thereby supporting its substantial equivalence."
| Acceptance Criteria (Common to Orthopaedic Implants) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| - ASTM F1264-03:2012 Compliance (Intramedullary Fixation Devices) | Testing completed; "performs comparably to predicate devices." |
| - ASTM F384-06:2006 Compliance (Angled Orthopedic Fracture Fixation Devices) | Testing completed; "performs comparably to predicate devices." |
| - ISO 7206-04:2002 Compliance (Endurance of Stemmed Femoral Components) | Testing completed; "performs comparably to predicate devices." |
| - ASTM F543-07 Compliance (Metallic Medical Bone Screws) | Testing completed; "performs comparably to predicate devices." |
| - Cut-out strength from femoral head | Cadaver testing performed; results support substantial equivalence. |
| - Simulated expansion testing of the X-Bolt device | Testing performed; results support substantial equivalence. |
| Biocompatibility: | |
| - ISO 10993 Compliance (Genotoxicity, Cytotoxicity, Local Effects, Irritation/Hypersensitivity, Systemic Toxicity) | Testing completed in accordance with ISO 10993 Parts 3, 5, 6, 10, 11; "demonstrates its biocompatibility." |
| Sterility: | |
| - Pyrogen LAL testing | Testing completed; results support substantial equivalence. |
| - Sterility (Irradiation) | Stated as Sterile (irradiation); aligned with predicate devices. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated for each test. For biomechanical testing, often a defined number of samples (e.g., typically N=6 or more for each test condition) are required by the standards, but the exact numbers are not provided in this summary. Cadaver testing details are not quantified in terms of sample size.
- Data Provenance: Not specified. Standardized ASTM and ISO tests are laboratory-based. Cadaver testing would be conducted in a laboratory setting. No mention of geographical origin for data or if it's retrospective/prospective is relevant for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: N/A. Ground truth for mechanical and biocompatibility testing is established by adhering to widely accepted engineering and biological test standards (ASTM, ISO). These do not typically involve human expert consensus for "ground truth" in the way AI/ML models do.
- Qualifications of Experts: N/A. The "ground truth" is typically the physical and chemical properties of the materials and the mechanical performance defined by the test standards, measured by qualified laboratory personnel using calibrated equipment.
4. Adjudication method for the test set
- Adjudication Method: N/A. The testing described does not involve human interpretation or subjective assessment that would require an adjudication method. Results are quantitative measurements against defined standards.
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
- MRMC Study: N/A. This is a physical medical device (implant), not an AI/ML diagnostic or assistive tool. MRMC studies are specific to evaluating diagnostic imaging systems and reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: N/A. See above; this is not an algorithm or software device.
7. The type of ground truth used
- Type of Ground Truth: For the mechanical and biocompatibility testing, the "ground truth" is defined by the requirements and methodologies outlined in the referenced ISO and ASTM standards. For example, for mechanical tests, the ground truth is the measured force, displacement, or fatigue life against the specified limits. For biocompatibility, it's the biological response (or lack thereof) according to the ISO 10993 series.
8. The sample size for the training set
- Training Set Sample Size: N/A. This device is not an AI/ML product; therefore, there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: N/A. As there is no AI/ML component, there is no training set or associated ground truth establishment process.
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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
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: 353 1 845 6011
Contact: Brian Thornes, MCh FRCSI MBA Founder & CEO Email: brian.thornes@x-bolt.com
2. Prepared by
Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street, NW, Suite 1000 Washington, DC 20001 Phone: 202.552.5800
Contact: Ms. Hollace Saas Rhodes Senior Director, Orthopedic Regulatory Affairs Email: hrhodes@mcra.com
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/PlateCombination, Multiple Component, Single/Multiple ComponentMetallic 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
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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
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- 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.
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| 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 |
| RegulationNumber | 21 CFR 888.3020 | 21 CFR 888.3020 |
| Classification | II | II |
| Indications foruse: | The X-BOLT® IM Hip Nailing System isintended for use in fracture fixation inthe femur in the adult population. TheX-BOLT® IM Hip Nailing System isindicated for use in:• Intertrochanteric andsubtrochanteric fractures• Segmental fractures• Comminuted fractures• Fractures involving osteopenicand osteoporotic bone• Pathological fractures• Fractures with bone loss• Pseudoarthrosis, non-union,mal-union, and delayed union• Surgically created defects suchas osteotomies | The Zimmer® Natural Nail™System is intended for temporaryfixation and stabilization of thebone. Indications for use of thegreater Trochanter and PiriformisFossa nails in the femur include:• Compound and simple shaftfractures• Proximal, metaphyseal, anddistal shaft fractures• Segmental fractures• Comminuted fractures• Fractures involving osteopenicand osteoporotic bone• Pathological fractures• Fractures with bone loss• Pseudoarthrosis, non-union,mal-union, and delayed union• Periprosthetic fractures• Surgically created defects suchas osteotomies• Intertrochanteric andsubtrochanteric fractures |
| Componentsand Design | • Intramedullary Nail, Fixation Bolt,Distal Screws• Achieves fixation via fourexpanding wings that expandprecisely into premade cavitiesand are designed to resist cut-out | • Intramedullary nail, Lag Screw,and Distal Screw• Achieves fixation via a threadedsliding lag screw |
| Materials | Implant grade stainless steelParylene C Coating | Titanium Alloy (Ti-6Al-4V) |
| Manufacturer | X-BOLT® Orthopaedics | Stryker Howmedica Osteonics |
| Trade Name | X-BOLT® Dynamic Hip PlatingSystem | Omega 3 System |
| 510(k) Number | Subject device | K062066 |
| Product Code | KTT | KTT |
| RegulationNumber | 21 CFR 888.3030 | 21 CFR 888.3030 |
| Classification | II | II |
| Indications foruse: | The X-BOLT® Dynamic HipPlating System is intended foruse in fracture fixation in theproximal femur in the adultpopulation. The X-BOLT®Dynamic Hip Plating System isindicated for use in:• Intracapsular andextracapsular fractures of thefemoral neck• Trochanteric fractures of theproximal femur• Stable subtrochantericfractures of the proximalfemur | The Omega (Systems) areintended for use in thetemporary stabilization of typesof fractures to the proximal anddistal femur. The subjectdevices are indicated forfixation of proximal and distalfemoral fractures including butnot limited to:• Intracapsular and basal neckfractures includingtranscervical and subcapitalfractures• Intertrochanteric fractures• Subtrochanteric fractures• Supracondylar fractures• Osteotomies for patients withdiseases or deformities of thehip• Hip arthrodesis |
| Components andDesign | • Implant grade stainless steelplate, screws and fixationbolt• Achieves fixation via fourexpanding wings thatexpand precisely intopremade cavities and aredesigned to resist cut-out | • Implant grade stainless steelplate, screws and lag screw• Achieves fixation via athreaded sliding lag screw |
| Materials | Implant grade stainless steelParylene-C coating | Implant grade stainless steel |
| Sterility | Sterile (irradiation) | Sterile |
| Manufacturer | X-BOLT® Orthopaedics | Stryker Howmedica Osteonics |
| Trade Name | X-BOLT® Dynamic Hip PlatingSystem | Omega 3 System |
| Dimensions | The X-BOLT® is an expandinghip bolt available in 10different lengths rangingfrom 80mm to 125mm in5mm increments. | The Omega 3 bolt is available invarious sizes ranging from50mm to 140 mm in 5mmincrements |
| The X-BOLT® Dynamic HipPlate is a 135° angled metalplate and is available in fourdifferent sizes - 2-hole,4- hole, 5-hole and 6-holeconfigurations. | The Omega 3 system plate isavailable in keyed and keylessconfigurations, in short andstandard barrel options,ranging from 2 hole to 12holes, with multiple optionsfor plate angles (130 – 150°)and in lengths from 47 –207mm. | |
| X-BOLT® Cortical Screws are4.5mm in diameter andavailable in 10 different sizesfrom 30mm to 48mm in 2mmincrements | Omega cortical screws are4.5mm in diameter andavailable in 14-110 mm in 2-5mm increments. Otherlocking screws also offered (14-95mm). |
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.
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Comparison Table: X-BOLT® Dynamic Hip Plate vs. Stryker Howmedica Osteonics Omega 3 System
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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.
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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.
§ 888.3020 Intramedullary fixation rod.
(a)
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.(b)
Classification. Class II.