What X-BOLT Orthapaedics does

X-BOLT Orthopaedics is a Dublin, Ireland-based medical device company founded in 2007 that develops expandable bolt orthopedic fixation technology, primarily targeting fragility hip fractures in aging populations. The company's core differentiator is its proprietary mechanical expansion mechanism, which expands within bone to provide enhanced fixation strength compared to conventional screw-based devices. The technology is protected by multiple patents including US 2010/0145396, PCT WO2018/029374, and PCT EP2020/055946, and the company operates under ISO 13485 quality certification.

The commercial portfolio includes the Pro-X1 Trochanteric Nail and the XHS Hip Fracture Plating System, with a development pipeline extending to retrograde nails, humeral nails, spinal bolts, pelvic fixation devices, and tibial nails. Clinical evidence supporting the technology includes the WHITE1 randomized controlled trial (n=100) showing a 0% reoperation rate and the WHITE4 RCT (n=1,140) reporting a 0.8% cut-out rate, which is described as the lowest in the largest randomized study of its kind. The Pro-X1 received FDA 510(k) clearance in March 2023.

X-BOLT operates a direct hospital sales model and initiated limited US commercialization in 20 hospitals in March 2024, with over 50 additional hospitals reported to have expressed demand. The company has secured a Vizient Innovative Technology Contract for GPO procurement access and an Osso VR partnership for surgical training. Total disclosed funding is approximately $5.95M, including a $2.45M seed round in January 2014 and a $3.5M Series A in October 2023 led by BVP. Management forecasts $2M in 2024 revenue and $13M in 2025.

Name

X-BOLT Orthapaedics

Legal name

X-Bolt Orthopedics Limited

Website

https://x-bolt.com

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

1–10 employees

Short description

X-BOLT Orthopaedics is a Dublin-based medical device company developing expandable bolt orthopedic fixation technology for fragility hip fractures. It serves US and European hospitals with FDA-cleared products and a broader trauma pipeline.

Ownership category

akta.pro rank

Product category

Orthopaedic Trauma Fixation Implants

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112)

SIC

Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

Orthopedic Trauma & Extremities Fixation (Plates/Screws/Nails/External Fixation) (HLAHAEAB)

akta.pro secondary industries

Spine (Orthopedic Spine) (HLAKALAE), Orthopedic Joint Reconstruction Implants (Hip/Knee/Shoulder/Elbow/Ankle) (HLAHAEAA)

Keywords

• Orthopedic trauma implants
• Expandable bone fixation
• Hip fracture devices
• Trochanteric nailing
• Osteoporotic bone fixation

Headquarters

HQ city

Dublin

HQ country

Ireland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Marketing or Sales, Operations, Infrastructure, Personnel

Revenue model

1. Medical Device Hardware Sales: X-Bolt generates revenue from the sale of its titanium expandable bolt orthopedic implant systems (Pro-X1 Trochanteric Nail, XHS Hip Plating System) to hospitals and healthcare providers. Revenue is one-time per procedure, driven by surgical volume. The company forecasts $2M revenue in 2024 and $13M in 2025 as US commercialization scales.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels15 records

Core offering

X-BOLT Orthopaedics designs, manufactures, and commercializes titanium orthopaedic trauma fixation implants built on a patented in-situ expandable bolt technology. Its FDA-cleared Pro-X1 Trochanteric Nail and XHS Hip Plating System replace traditional lag screws for hip fracture fixation, while a pipeline extends the same expandable bolt platform to femoral, humeral, pelvic, tibial, and spinal applications. The devices are sold one-time per surgical procedure directly to hospitals and orthopaedic trauma surgeons through US field sales, global distributors, and a Vizient GPO contract.

Product overview

X-BOLT Orthopaedics is a medical device company offering a portfolio of orthopedic fixation products based on patented expandable bolt technology. The core portfolio includes the FDA-cleared Pro-X1 Trochanteric Nail and XHS Hip Fracture Plating System, both featuring an expanding bolt mechanism that provides superior rotational stability and anchorage in osteoporotic bone compared to traditional screw fixation. The pipeline includes specialty nails for the femur (Karibu Retrograde Nail), humerus (Pendulum Humeral Nail), and spine (Spinal DragonBolt), plus pelvic fixation devices. All products share the common expandable bolt technology platform designed to reduce cut-out failure and reoperation rates in hip and long bone fracture fixation.

Differentiator

Problem solved

Functional benefit

Brands

• Pro-X1: Trochanteric nailing system - flagship titanium nail construct with reversibly expanding bolt for hip fracture fixation.
• XHS
• Karibu
• Pendulum
• DragonBolt

Products and services

• Pro-X1 Trochanteric Nail FDA-cleared (K221621) titanium trochanteric nailing system featuring a reversibly expanding bolt that replaces traditional lag screws to provide superior rotational stability and anchorage in osteoporotic bone; designed to reduce cut-out and reoperation rates in intertrochanteric, subtrochanteric, segmental, comminuted, pathological fractures and pseudoarthrosis/non-union cases in adults with osteopenia or osteoporosis. Sold to hospitals and orthopaedic trauma surgeons.
• XHS Hip Fracture Plating System Hip fracture plating fixation system using expanding bolt technology for rotationally stable femoral head fixation; demonstrated cut-out rates below 1% in the WHITE1 and WHITE4 RCTs. Sold to hospitals and orthopaedic trauma surgeons.
• Karibu Retrograde Nail Retrograde femoral nail featuring double-ended X-BOLTs locked distally for strong distal fixation intended to enable earlier weight-bearing in distal femur fractures (patent pending US 63/026,286). Pipeline product; targeting global orthopaedic trauma distributor partners.
• Pendulum Humeral Nail Humeral nailing system with distal expansion zone that eliminates the need for distal locking screws. Manufactured in titanium with T20 screwdriver actuation/retraction. Pipeline product; currently not FDA approved for US use, targeted at international markets via distributors.
• Spinal DragonBolt Pedicle Screw System Expandable spinal pedicle screw fixation system designed to address pedicle screw loosening (about 23% rate in non-augmented osteoporotic cases). Features reversible screwdriver-actuated expansion, cement-free fixation, and haptic anchorage with bone quality feedback. Not currently FDA approved for US use.
• Pelvic TightBolt Fixation Device Pelvic fixation device featuring a flexible-to-tight deploying X-Bolt portion that provides strong anchorage and intra-fracture compression. Patent pending. Pipeline product targeted at international orthopaedic trauma distributors.
• Springboard Tibial Nail Tibial nail featuring a strut for more proximal fixation and a micromotion suspension mechanism intended to support fracture healing dynamics. Pipeline product.

Quantifiable outcome

• 0.8% cut-out rate for X-Bolt vs 4-5% for standard SHS (Norwegian Hip Fracture Register, ~31,000 patients)
• +7 more outcomes

Named customers3 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature11 records

Partnerships

Two partnerships are on record, tiered core and supporting.

• VizientcoreStrategic or Co-development Partner · 3 February 2026Vizient awarded an Innovative Technology contract for the Pro-X1 Trochanteric Nail following review by hospital experts on Vizient's client-led councils. Vizient is the nation's largest provider-driven healthcare performance improvement company managing $156B+ in annual purchasing volume. The contract enables X-Bolt to expand national access to its expandable bolt technology across Vizient's diverse hospital client base.
• Osso VRsupportingTechnology or Integration · 3 October 2023X-Bolt partnered with Osso VR to create an immersive Virtual Reality application for surgical training and product demonstration. Debuted at OTA Seattle 2023. The VR experience is designed to accelerate surgeon adoption by demystifying the technology, allowing surgeons to experience the procedure in a risk-free virtual environment before performing real surgeries.

Scale indicators11 records

Recent moves6 records

Expansion highlights4 records

Broad incumbents

• Stryker: Stryker's Gamma3 and Gamma4 Trochanteric Nails directly compete with X-Bolt's Pro-X1 in hip fracture fixation. Stryker is a broad orthopedic incumbent with a global salesforce and full trauma portfolio, and serves as the reference competitor X-Bolt must displace in US hospitals.
• Smith+Nephew: Smith+Nephew's InterTAN and TRIGEN hip nailing systems are among the most clinically validated trochanteric fixation products, competing head-to-head with X-Bolt's Pro-X1. As a broad incumbent with established orthopedic sales channels, Smith+Nephew represents the second major displacement target for X-Bolt.
• DePuy Synthes (Johnson & Johnson MedTech): DePuy Synthes markets the TFN-ADVANCE Pro and PFNA nailing systems, two of the most widely used trochanteric fixation devices globally. The combined DePuy Synthes + J&J MedTech distribution and surgeon training infrastructure makes it one of X-Bolt's most entrenched competitors.
• Zimmer Biomet: Zimmer Biomet's Natural Nail and Affixus hip fracture nailing systems and hip plating portfolio directly overlap with X-Bolt's Pro-X1 and XHS products. As a broad incumbent with deep orthopedic relationships, Zimmer Biomet sets the standard X-Bolt must beat for hospital VAC approvals.
• B. Braun (Aesculap): B. Braun's Aesculap division markets the Proximal Femoral Nail (PFN) and Targon PF systems, both direct competitors in hip fracture intramedullary fixation. Aesculap serves European hospitals extensively, making it a particular comparison point for X-Bolt's planned EU expansion.
• Orthofix Medical: Orthofix markets the Centronail and Gorilla bone growth stimulation and trauma fixation products with overlap to X-Bolt's orthopedic trauma applications. Orthofix's combination of trauma and biologics makes it an adjacent incumbent X-Bolt may compete with or partner alongside.
• Exactech: Exactech specializes in hip and knee arthroplasty products including hip fracture fixation offerings, and is comparable to X-Bolt given overlapping hip trauma applications. Exactech's recent acquisition by TPG Capital provides a relevant precedent for strategic investor exits in this space.

Direct peers

• Acumed: Acumed is a specialty orthopedic trauma company of similar size and focus to X-Bolt, with an upper extremity and lower extremity plating/nailing portfolio. Comparable as a mid-sized, focused trauma device maker competing against the same tier-1 incumbents.

Emerging players

• OsteoMed: OsteoMed is a small orthopedic trauma and craniomaxillofacial device company with a similar size profile to X-Bolt. Both companies compete for shelf space in trauma-focused hospital VAC committees without the marketing budgets of the top-four incumbents.

Others

• Arthrex: Arthrex is the company that licensed founder Dr. Brian Thornes' previous TightRope ankle device invention in 2003 and where he trained as an orthopedic surgeon. Arthrex represents a potential strategic acquirer and demonstrates founder credibility, even though it operates in adjacent sports medicine rather than direct hip trauma fixation.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/HipFixationCo
• LinkedInlinkedin.com/company/x-bolt-orthopaedics

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds3 records

Investors7 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about X-BOLT Orthapaedics