Resolve Surgical Technologies
Resolve Surgical Technologies is a pioneer in the orthopedic industry, serving as a Contract Development and Manufacturing Organization (CDMO+) that accelerates bringing innovative orthopedic solutions to market. With a comprehensive in-house capability to design, develop, manufacture, and maintain medical devices, Resolve focuses on delivering speed to revenue for its OEM partners through its unique CDMO+ model. The company emphasizes collaboration, innovation, and operational excellence across various market segments including Spine, Trauma, Cardiothoracic, and Reconstructive Surgery.
Industries
Nr. of Employees
large (251-1000)
Resolve Surgical Technologies
Marquette, Michigan, United States, North America
Products
Sternal closure fixation plates and kits
Integrated plate-and-cable fixation systems supplied with associated instruments and sterile-packed kits for sternal closure applications.
Cerclage cables and crimp systems
Braided and solid cable cerclage systems, crimps and crimping/tensioning instruments across multiple diameters and materials for orthopedic fixation.
Cervical plate and spinal fixation systems
Low-profile cervical plates, single-screw-per-level systems, pedicle screw and rod systems and complete instrument sets for anterior and posterior spinal procedures.
Interbody spacer implants (additive manufactured)
Near-net shape 3D-printed interbody spacer implants with precision-machined instrument interfaces using PEEK/PEKK polymers designed for bone integration and radiolucency.
Surgical instruments (tensioners, cutters, inserters, retractors)
A portfolio of reusable and disposable instruments including inline and pistol-grip tensioners, cable cutters, inserters with clamping interfaces and lateral retractor systems.
Cannulated screws and extremity plates
Design and manufacture of cannulated screws in stainless steel and titanium and active-compression extremity plates with novel metallurgical features for sustained compression.
Sternal closure fixation plates and kits
Integrated plate-and-cable fixation systems supplied with associated instruments and sterile-packed kits for sternal closure applications.
Cerclage cables and crimp systems
Braided and solid cable cerclage systems, crimps and crimping/tensioning instruments across multiple diameters and materials for orthopedic fixation.
Cervical plate and spinal fixation systems
Low-profile cervical plates, single-screw-per-level systems, pedicle screw and rod systems and complete instrument sets for anterior and posterior spinal procedures.
Interbody spacer implants (additive manufactured)
Near-net shape 3D-printed interbody spacer implants with precision-machined instrument interfaces using PEEK/PEKK polymers designed for bone integration and radiolucency.
Surgical instruments (tensioners, cutters, inserters, retractors)
A portfolio of reusable and disposable instruments including inline and pistol-grip tensioners, cable cutters, inserters with clamping interfaces and lateral retractor systems.
Cannulated screws and extremity plates
Design and manufacture of cannulated screws in stainless steel and titanium and active-compression extremity plates with novel metallurgical features for sustained compression.
Services
End-to-end services from concept through regulatory submission, on-site manufacturing, sterile packaging and post-market maintenance tailored for orthopedic OEMs.
Preparation of regulatory submissions (510(k), EU MDR, UKCA), regulatory strategy, technical file updates and clinical documentation including CEP, CER, PMCF and SSCP.
Gap assessments, DHF assimilation, translating document structures and transferring documentation to an EU MDR-compliant quality system to facilitate post-acquisition integration.
Translation of R&D designs to production including design for manufacturability, process development, tooling/fixturing and lead-time optimization.
Production services for metal and polymer implants, instrument sets, disposable components, anodization, assembly and sterile packaging.
Ongoing post-market clinical follow-up, adverse event reporting, annual reports and change impact assessments to maintain market compliance.
End-to-end services from concept through regulatory submission, on-site manufacturing, sterile packaging and post-market maintenance tailored for orthopedic OEMs.
Preparation of regulatory submissions (510(k), EU MDR, UKCA), regulatory strategy, technical file updates and clinical documentation including CEP, CER, PMCF and SSCP.
Gap assessments, DHF assimilation, translating document structures and transferring documentation to an EU MDR-compliant quality system to facilitate post-acquisition integration.
Translation of R&D designs to production including design for manufacturability, process development, tooling/fixturing and lead-time optimization.
Production services for metal and polymer implants, instrument sets, disposable components, anodization, assembly and sterile packaging.
Ongoing post-market clinical follow-up, adverse event reporting, annual reports and change impact assessments to maintain market compliance.
Expertise Areas
- Orthopedic implant design and manufacturing
- Integrated CDMO+ services for medical devices
- Quality management system integration and compliance
- Global regulatory strategy and submission support (510(k), EU MDR, UKCA)
Key Technologies
- Additive manufacturing (3D printing, near-net shape)
- Precision CNC machining and fixturing
- Finite element analysis (FEA)
- Class 7 cleanroom manufacturing