Orthopedic Device Expertise
FDA-registered contract manufacturing for orthopedic devices. Cleanroom assembly, ISO 11607 packaging validation, EtO/gamma sterilization, and loaner kit reprocessing under one ISO 13485 quality system.
Orthopedic medical devices must meet rigorous performance, safety, and regulatory standards to ensure they function reliably and protect patients. With increasing FDA and MDR oversight, orthopedic manufacturers need a trusted partner to streamline production, maintain compliance, and optimize time to market.
LSO partners with leading and emerging orthopedic device OEMs to provide scalable, compliant, and cost-effective contract manufacturing — so your devices meet regulatory requirements and reach the market faster without sacrificing quality.
Orthopedic Device Capabilities
Life Science Outsourcing provides specialized expertise in the manufacturing, packaging, and sterilization of orthopedic devices.
Cleaning & Decontamination
We deliver precision cleaning and decontamination to remove contaminants, ensuring orthopedic implants and instruments meet sterility and biocompatibility standards.
Cleanroom Assembly & Kitting
From implantable joint replacements to surgical fixation kits, LSO offers turnkey cleanroom manufacturing and kitting solutions for orthopedic devices.
Labeling
Our in-house labeling capabilities ensure full compliance with FDA, ISO, and UDI (Unique Device Identification) requirements while maintaining the highest quality.
Sterilization
LSO provides contract sterilization and validation services designed for both single-use and reusable orthopedic instruments and implants.
Product Portfolio
LSO supports the full range of orthopedic devices — from implantable joint replacements and spinal fixation systems to trauma plates, screws, and surgical instrument kits. Whether your product is a Class II sterile implant or a complex multi-component surgical kit, our cleanroom assembly, validated packaging, and sterilization capabilities are matched to orthopedic-specific requirements.
Common device types include: total joint replacement components (hip, knee, shoulder), spinal fusion and fixation hardware, trauma fixation plates and screws, arthroscopic instruments, orthobiologics and bioabsorbable implants, and reusable surgical instrument loaner kits.
LSO supports the full range of orthopedic devices — from implantable joint replacements and spinal fixation systems to trauma plates, screws, and surgical instrument kits. Common device types include:
Total joint replacement components (hip, knee, shoulder). Spinal fusion and fixation hardware. Trauma fixation plates and screws. Arthroscopic instruments. Orthobiologics and bioabsorbable implants. Reusable surgical instrument loaner kits.
Why LSO for Orthopedic Devices?
Orthopedic devices demand a manufacturing partner with specialized cleanroom environments, bioabsorbable material handling, and the capacity to scale. LSO brings 25+ years of experience with orthopedic OEMs, 12 cleanrooms (Class 5–8) including a Class 7 dry room for moisture-sensitive materials, and multi-site capacity across California, New Hampshire, and Costa Rica.
The consolidation advantage is particularly strong for orthopedic OEMs: assembly, packaging, sterilization, and loaner kit reprocessing under one quality system means fewer vendors, fewer audits, and faster turnaround. Your QA team manages one supplier relationship instead of four.
FDA-Registered
Manufacturing Facility
ISO 13485
Certified Quality System
12 Cleanrooms
Class 5–8
125,000+ Sq Ft
Regulated Manufacturing
3 Facilities
CA | NH | Costa Rica
Ready to discuss your project?
Talk to a specialist about orthopedic device expertise manufacturing needs.