Able Medical Devices received FDA 510(k) clearance for the Valkyrie™ Thoracic Fixation System - the first-to-market, fully disposable bioactive sternal plate system. The system features PEEK (polyether ether ketone) implants with proprietary HAnano surface treatment that promotes cell adhesion and bone synthesis, making it suitable for sternal fixation, chest wall fracture stabilization, and sternal reconstruction in patients with normal and/or poor bone quality.
Able Medical announced that over 10,000 U.S. surgeries have been performed using the Valkyrie Thoracic Fixation System. Additionally, in January 2026, the company received FDA 510(k) clearance for the Valkyrie RIB System for rib and chest wall fracture stabilization, expanding the Valkyrie product portfolio.
Company Overview (Updated April 2026)
Able Medical Devices is a global medical device manufacturer headquartered in Marquette, Michigan, USA. Established in 2018, the company operates as a wholly-owned subsidiary of J.M. Longyear, a privately held Michigan-based investment and asset management firm. Able Medical designs and manufactures high-quality surgical implants and instruments, specializing in innovative cardiothoracic products including the industry's first bioactive PEEK-based sternal closure systems and comprehensive orthopedic implant solutions.
Corporate Structure:
- Parent Company: J.M. Longyear (privately held, Michigan-based)
- Headquarters: Marquette, Michigan, USA (new facility operational since October 2025)
- Facility Size: 30,000 square feet (expandable to 100,000 sq ft)
- Employees: 70+ full-time team members, expanding to 110+ with new hiring
- Year Founded: 2018
- Industry: Medical Device Manufacturing / Contract Manufacturing
Historical Evolution:
- 2018: Company founded and began operations
- 2021: Launched the Valkyrie Thoracic Fixation System; completed first surgeries
- January 2023: Introduced Valkyrie Looped Sternotomy Sutures, complementing the thoracic fixation portfolio
- 2022: Recognized as one of Michigan 50 Companies to Watch by Michigan Celebrates Small Business awards
- July 2024: Broke ground on new Marquette facility
- October 15, 2025: Officially opened new Marquette manufacturing facility with ribbon cutting ceremony
- January 28, 2026: FDA 510(k) clearance for Valkyrie RIB System; announced 10,000+ U.S. surgeries milestone
- January 29 - February 1, 2026: Exhibited at STS 2026 Annual Meeting in New Orleans, showcasing PEEK sternal closure technology
- March 16, 2026: FDA 510(k) clearance for Valkyrie Thoracic Fixation System (bioactive PEEK sternal plate system with HAnano surface)
Manufacturing Facility & Capabilities
Marquette Facility (Opened October 2025)
Facility Specifications:
- Location: South McClellan Avenue near Division Street, Marquette, Michigan
- Size: 30,000 square feet of world-class manufacturing space (expandable to 100,000 sq ft)
- Investment: $13 million capital investment
- Job Creation: 40 new jobs expected with expansion
- Grant Support: $500,000 from Michigan Business Development Program (MEDC)
Manufacturing Capabilities:
- CNC Swiss turning (multi-axis precision mACHining)
- CNC milling
- Gun drilling
- Wire EDM (Electrical Discharge Machining)
- Laser welding
- Surface grinding
- Buffing and blasting
- Prototyping and custom instrument fabrication
Quality & Regulatory:
- ISO 13485:2016 certified quality management system
- FDA registered manufacturing facility
- Experience with Class I, II, and III medical devices
- MDR (Medical Device Regulation) preparation background
Product Portfolio & FDA Clearances (2026 Update)
Valkyrie Thoracic Fixation System (FDA 510(k) Cleared March 2026)
Breakthrough Innovation:
- First-to-market, fully disposable bioactive sternal plate system
- Material: PEEK (polyether ether ketone) - radiolucent, lightweight, biocompatible polymer
- HAnano Surface Treatment: Proprietary bioactive surface that promotes cell adhesion and bone synthesis
- Indications: Sternal fixation, chest wall fracture stabilization, sternal reconstruction
- Patient Population: Suitable for patients with normal and/or poor bone quality
- Advantages: Radiolucency allows improved post-operative imaging; reduced stress shielding; patient comfort
- Clinical Milestone: Over 10,000 U.S. surgeries completed as of January 2026
Valkyrie RIB System (FDA 510(k) Cleared January 2026)
Rib and Chest Wall Fracture Stabilization:
- System for stabilization and fixation of rib and chest wall fractures
- Post-sternotomy sternal fixation capabilities
- Expands Valkyrie product portfolio beyond sternal closure
- Part of comprehensive thoracic fixation platform
Valkyrie Looped Sternotomy Sutures (January 2023)
- Stainless steel wire sutures for chest closure after open-heart surgery
- 14-inch sutures available in 48mm and 55mm sizes
- Three different needle configurations
- Double the surface area of single wires for robust sternal closure
- Complements thoracic fixation system for complete closure portfolio
Orthopedic Implants & Contract Manufacturing
Implant Types:
- Screws, plates, rods, hooks
- Interbody devices
- Lateral connectors, cross connectors
- Assemblies and custom implant configurations
Market Segments Served:
- Spine, Hip and Knee, Foot and Ankle, Shoulder, Thoracic, Cranial Maxillofacial (CMF), Dental, Trauma
Services:
- Product development and design compliance
- Design control and risk management
- Lean manufacturing methodologies
- Prototyping to full-scale production
Leadership Team
Executive Management
Steve Hicks: President & CEO of J.M. Longyear (Parent Company) - Oversees strategic direction and investment
Martin Deloria: Vice President & Managing Director - Oversees day-to-day operations and strategic growth initiatives; led new facility expansion
Peter Didyk: Senior Vice President & Managing Director - Oversaw Valkyrie PEEK sternal closure system development and FDA clearance process
Adam Paltzer: Vice President of Operations - Led MEDC engagement and manufacturing operations
Jeffrey Gilhool: Senior Director of Marketing - Media contact and trade show coordination (STS 2026)
Katie Barron: Senior Program Manager - Led Valkyrie Looped Sutures and RIB system development
Awards & Recognition
Michigan Celebrates Small Business (2022)
- Named one of Michigan 50 Companies to Watch
- Recognized for Rapid growth and innovation from the Upper Peninsula in the fast-paced medical device market
Strategic Partnerships & Support
Michigan Economic Development Corporation (MEDC)
- $500,000 Michigan Business Development Program grant supported facility expansion
- System for Integrated Growth (SIG) engagement via Edward Lowe Foundation
Educational Partnerships:
- Collaboration with Northern Michigan University and Michigan Technological University
- Internship programs building future workforce pipeline
Market Position & Competitive Landscape
Differentiation
First-to-Market Bioactive PEEK Technology:
- Only company offering bioactive PEEK sternal plate system with HAnano surface treatment
- First fully disposable sternal plate system (no reusable instrumentation required)
- PEEK provides radiolucency (improved imaging), reduced stress shielding, and patient comfort vs. metal
Geographic & Operational Advantages:
- Located in Michigan's Upper Peninsula with lower operating costs
- Access to outdoor recreational opportunities for employee retention
- Proximity to Northern Michigan University and Michigan Tech for talent pipeline
2026 Outlook & Strategic Direction
Recent Achievements & Next Steps
- Q1 2026: FDA 510(k) clearance for Valkyrie RIB System (January)
- Q1 2026: STS 2026 exhibition and 10,000+ surgeries milestone announcement (January)
- Q1 2026: FDA 510(k) clearance for Valkyrie Thoracic Fixation System with bioactive HAnano surface (March)
- Commercial Expansion: Scaling manufacturing to meet demand for newly cleared products
- Product Pipeline: Continuing development of next-generation thoracic fixation solutions
Contact Information
Headquarters
Address: Able Medical Devices, Marquette, Michigan, USA
Website: www.ablemedicaldevices.com
Media Contact: Jeffrey Gilhool, Senior Director of Marketing, jeffreyg@abledev.us, (906) 373-9539
Trade Show & Events (2026)
- STS 2026: Society of Thoracic Surgeons Annual Meeting, New Orleans, Louisiana, January 29 - February 1, 2026, Booth 1009
Keywords: Able Medical Devices, Valkyrie Thoracic Fixation System, Valkyrie RIB System, Valkyrie Looped Sutures, PEEK sternal closure, HAnano surface, bioactive sternal plate, Marquette, Michigan, J.M. Longyear, Steve Hicks, Martin Deloria, Peter Didyk, FDA 510k clearance, cardiothoracic implants, orthopedic implants, sternotomy, rib fracture, chest wall reconstruction, 10,000 surgeries, ISO 13485, 2018
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