Lower Extremity Trauma  ·  Malvern, PA  ·  510(k) Pathway

The answer
to ankle fracture.

Crossover Medical is developing two implant systems for the distal fibula and the syndesmosis — the most common injuries in operative ankle fracture care, and two of the least modernized.

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~585K
US ankle fractures per year
~25%
require operative fixation
$650M+
US addressable market across our two indications
2
Class II systems in development
Market Opportunity

A focused position in a
$4.7B US market.

Crossover targets two high-volume, under-innovated indications within US trauma fixation. Sizing works down from the total market to our addressable segment.

US trauma fixation devicesAll segments, internal and external
~$4.7B
Internal fixationPlates, nails, screws — ~65% of the market
~$3.4B
Foot, ankle & distal lower extremityAnkle trauma is the largest distal segment
~$1.5B
Crossover targetFibular fixation + syndesmosis repair
$650M+
System A  ·  Fibular Fixation

The largest operative ankle segment

Most operative ankle fractures involve the lateral malleolus, and the majority are still treated with a plate and screws through an open lateral incision.

~2/3
of operative ankle fractures are isolated fibular
~9%
of all fractures involve the distal fibula
65+
a fast-growing patient cohort
Intramedullary fixation is gaining clinical support, and the first generation of fibular nails has validated the category. Share is still overwhelmingly held by plating.
System B  ·  Syndesmosis Repair

The fastest-growing segment in ankle

Surgeons have already shown they will adopt a better syndesmotic implant: suture-button devices have been steadily displacing screws.

~20%
of operative ankle fractures involve the syndesmosis
$143M
global market, 2024
$323M
by 2034 · 8.5% CAGR
The market pays for better outcomes, not lower prices. The next step is reproducible, controlled reduction and tensioning.

Sources: GM Insights, US Trauma Fixation Market 2024 ($4.7B, projected $6.2B by 2034); iData Research, Trauma MedSuite; Fact.MR, Syndesmosis Repair Market 2024–2034; NEISS; Scheer et al., J Foot Ankle Surg 2020; Crossover internal segment build-up. Figures are top-down estimates.

Clinical Need

Three problems surgeons
still work around.

The standard of care for the lateral ankle has changed little in thirty years. These are the outcomes our two systems are designed to improve.

Problem 01

Soft-tissue complications from lateral plating

~33%
complication rate after open plating in elderly patients, with ~19% requiring reoperation

A long lateral incision over thin, often compromised soft tissue drives wound breakdown and infection, especially in older, diabetic, and osteoporotic patients.

Our approach: less invasive intramedullary fixation. In a randomized trial, nailing produced significantly fewer wound infections than plating (p = 0.002) with equivalent function at one year.
Problem 02

Hardware that has to come out

30.7%
hardware removal rate after syndesmotic screw fixation, vs. 10.4% for suture buttons

Prominent plates and rigid screws lead to irritation, breakage, and second surgeries, adding cost for health systems and burden for patients.

Our approach: low-profile, load-sharing implants designed to stay in — reducing return trips to the OR.
Problem 03

Syndesmotic malreduction

Up to 52%
of syndesmoses found malreduced on postoperative CT in a landmark study

Reduction and tension are still largely set by surgeon feel. The result varies widely by surgeon and case, and malreduction is linked to poorer long-term function.

Our approach: a tensioned system built for reproducibility — taking the variability out of how reduction and tension are applied.
The Patient

Volume grows as the population ages.

50–54
peak age group, with a second peak at 65+
54%
of ankle fractures caused by simple falls
1 in 10
of all fractures is an ankle fracture

Sources: White et al., Bone Joint J (fibular nail vs. ORIF RCT, elderly); JBJS Am 2022; Walsh et al. meta-analysis; Cureus systematic review 2025; Tornetta, CORR (syndesmotic cost-effectiveness); Gardner et al., Foot Ankle Int 2006; NEISS.

Category Momentum

Strategics are investing
in this anatomy.

The past two years have brought more product and M&A activity in fibular nailing and syndesmotic fixation than the prior decade.

Oct 2024

Paragon 28

Launches the Phantom® Fibula Nail System, citing fewer soft-tissue complications, implant removals, and nonunions than plating.

Apr 2025

Zimmer Biomet

Completes its ~$1.2B acquisition of Paragon 28, adding a dedicated foot and ankle trauma portfolio.

Feb 2026

Stryker

Launches Synchfix™ EVT, a next-generation syndesmotic device with integrated suture tensioning.

Sep 2026

Fusion Orthopedics

Introduces the FibFix™ Fibula Nail System for distal fibula fractures.

1990sLateral plating becomes standard of care
2000sPre-contoured anatomic plates
2010sSuture buttons prove dynamic syndesmotic fixation
2020sFirst-generation fibular nails enter the market
NextA purpose-built platform for the lateral ankle
The question is no longer whether the category will move. It is which architecture comes next. Crossover is designed for that next step.

Sources: Paragon 28 press release (Business Wire, Oct 16, 2024); MassDevice (Apr 21, 2025); Stryker / Surgical Robotics Technology (Feb 24, 2026); ODT Magazine (Sep 18, 2026).

The Platform

Two systems. One anatomy.

Both systems are designed to be used independently or together, giving surgeons a single, coherent approach to the lateral ankle.

System A

Fibular Fixation System

In developmentClass II510(k) pathway

An intramedullary, load-sharing implant for distal fibula fractures.

  • Less invasive alternative to open lateral plating
  • Designed to reduce wound complications and hardware removal
  • Built for the older, higher-risk patient population
System B

Syndesmosis Repair System

In developmentClass II510(k) pathway

A tensioned fixation system for syndesmotic injuries.

  • Controlled, reproducible reduction and tensioning
  • Designed to reduce malreduction and variability between surgeons
  • Dynamic fixation without routine hardware removal

Planned public introduction: OTA Annual Meeting, 2027. Technical briefings are available under NDA to qualified strategic partners and clinical advisors.

Team

Experienced operators.
Leading clinical advisors.

A focused engineering and product team, supported by senior surgeon advisors in orthopaedic trauma and foot and ankle surgery.

CEO

Jeff O’Donnell Jr.

Chief Executive Officer · General Partner, Runway Healthcare

CTO

Bill Rhoda

Chief Technology Officer · General Partner, Runway Healthcare

Product

Kaileen Osisek

Product Manager

R&D

Mike Harper

Senior R&D Engineer

R&D

Caroline Ries

Associate Engineer

Clinical Advisors
SM

Samir Mehta, MD

University of Pennsylvania · Orthopaedic Trauma

LS

Lew Schon, MD

NYU Langone · Mercy Medical Center · Foot & Ankle

Board of Directors
Chair

Jeff O’Donnell Sr.

Executive Chairman

Director

Bill Rhoda

Founder & Director

Director

Jeff O’Donnell Jr.

Founder & Director

Director

Mark McMahan

Independent Director

Director

I.V. Hall

Independent Director

A Runway Healthcare companyEarly in, early out — concept through 510(k) clearance.
Waypoint OrthopedicsToetal SolutionsPace SurgicalCrossover Medical
Contact

Let’s talk.

We are engaging with strategic partners, surgeon advisors, and investors ahead of clearance.

Strategic Partners & Investors

Partnership briefing

For companies in lower-extremity orthopaedics and investors who want a closer look at our regulatory plan, IP position, and development timeline. Briefings are held under NDA.

Request a briefing
Surgeons

Clinical advisory

We are expanding our clinical advisory group with foot and ankle and trauma surgeons who treat a high volume of fibular and syndesmotic injuries.

Get in touch

Malvern, Pennsylvania · jeffjr@runwayhc.com

© 2026 Crossover Medical · A Runway Healthcare company.
Crossover Medical’s implant systems are in development and have not been cleared by the FDA. They are not available for sale.