CNC Milling
Precision 3-, 4-, and 5-axis CNC milling for complex orthopedic implant geometries. We deliver consistent repeatability and tight tolerances for bone plates, joint components, and implantable device housings.
When a patient's mobility and safety depend on every micron, you need a machining partner with zero tolerance for error. Criterion Precision Machining delivers ISO 13485-certified orthopedic implant components—crafted from titanium, stainless steel, and PEEK—with tolerances down to ±.0002". From prototype to full production, we machine the precision your patients deserve.
From complex multi-axis milling to high-precision Swiss turning, we offer the full spectrum of machining services for orthopedic implant components.
Precision 3-, 4-, and 5-axis CNC milling for complex orthopedic implant geometries. We deliver consistent repeatability and tight tolerances for bone plates, joint components, and implantable device housings.
High-precision CNC turning for cylindrical implant components such as screws, stems, and sleeves. Tolerances down to ±.0002" with smooth surface finishes critical for biocompatibility and implant performance.
Multi-axis Swiss turning for small-diameter, high-complexity orthopedic components. Ideal for micro-sized implant fasteners and intricate features in titanium, stainless steel, and specialty alloys.
Production-intent orthopedic implant prototypes machined on the same equipment as final production runs—ensuring seamless validation, regulatory confidence, and a direct path to full-volume manufacturing.
CMM-based dimensional inspection, OASIS optical measurement, and certified documentation including Certificates of Conformance—meeting the stringent traceability requirements of ISO 13485 and FDA standards.
Skilled machining of biocompatible materials including titanium alloys, cobalt-chrome, PEEK, and medical-grade stainless steels—the materials that define safe, durable orthopedic implant performance.
Orthopedic implants live inside patients for decades. That demands a machining partner who treats every component as mission-critical. Criterion Precision Machining brings over 70 years of precision manufacturing expertise, ISO 13485 certification, and advanced multi-axis machining to produce implant components that meet the tightest dimensional and surface finish requirements. From titanium hip stems to PEEK spinal components, we deliver the accuracy, traceability, and documentation your regulatory submissions and patients require.
See how leading medical device manufacturers trust Criterion for their most demanding orthopedic implant components.
We combine seven decades of machining expertise with industry-leading certifications and technology to deliver implant components with zero margin for error.
Our ISO 13485 and ISO 9001 certifications ensure every implant component meets stringent medical device quality management requirements.
We hold tolerances down to ±.0002"—the micro-precision that orthopedic implant fit, function, and patient safety demand.
Founded in 1953 and now in its third generation, Criterion has decades of machining experience serving 'No Failure' medical device industries.
From CMM inspection reports to Certificates of Conformance, we provide the complete documentation trail your FDA submissions and quality audits require.
Experienced professionals dedicated to precision, quality, and mission-critical manufacturing.
President
Tanya DiSalvo leads Criterion Precision Machining as its third-generation owner, carrying forward a legacy of precision excellence that began in 1953. Under her leadership, Criterion has grown into a nationally recognized, woman-owned precision machining company serving the medical device, aerospace, defense, and photonics industries. Tanya's vision has driven significant investment in advanced CNC technology, ISO 13485 quality systems, and a culture where every team member understands that the components they produce may one day be inside a patient. Her commitment to zero-defect manufacturing and continuous improvement has positioned Criterion as a trusted partner for orthopedic implant manufacturers who cannot afford failure. Tanya is also a proud WBENC-certified business leader, championing diversity in the precision manufacturing industry.
Estimator / Project Manager
Mike Pinchot serves as Estimator and Project Manager at Criterion Precision Machining, acting as a critical bridge between customer requirements and the shop floor. With deep knowledge of CNC machining processes, material costs, and manufacturing workflows, Mike ensures that every orthopedic implant project is accurately scoped, competitively priced, and delivered on schedule. He works closely with medical device engineers and procurement teams to evaluate design-for-manufacturability early in the process, helping customers avoid costly revisions and accelerate their path from prototype to production. Mike's proactive communication style and technical acumen make him the go-to contact for customers navigating tight deadlines and complex component specifications in the medical device space.
Chief Financial Officer
David Glass serves as Chief Financial Officer at Criterion Precision Machining, providing the financial leadership and operational stability that underpin the company's long-term investments in advanced machining technology and quality systems. His strategic oversight ensures that Criterion can continually reinvest in the equipment, certifications, and personnel required to serve the demanding orthopedic implant and medical device markets. David's financial discipline supports the company's ability to scale production capacity for customers transitioning from prototype to high-volume manufacturing, while maintaining the cost competitiveness that keeps Criterion a preferred machining partner for leading medical device OEMs and contract manufacturers.
Quality Manager
Kelly Marflak oversees Criterion's comprehensive quality management system as Quality Manager, ensuring every orthopedic implant component shipped meets the company's ISO 13485 and ISO 9001 standards. Kelly manages a multi-layered inspection program that includes a Global Advantage CMM with TESTASTAR-sm probe, the OASIS Optical Automatic Smart Inspection System, and Keyence measuring systems capable of evaluating up to 99 dimensions simultaneously. Her team ensures complete dimensional traceability, first-article inspection reporting, and Certificate of Conformance documentation for every production order. Kelly's rigorous approach to quality control is a cornerstone of Criterion's reputation as a trusted supplier to medical device manufacturers where zero-defect delivery is not optional.
What is a machined implant surface?
A machined implant surface refers to the finish achieved through precision CNC processes such as turning or milling, which creates a smooth, controlled topography on the implant. This surface finish is critical for implant fit, reducing stress concentrations, and in some designs, promoting osseointegration. At Criterion, we control surface finish to precise Ra values as specified by your engineering drawings.
Are orthopedic implants MRI compatible?
What medical parts are CNC machined?
What materials does Criterion machine for orthopedic implants?
What tolerances can Criterion hold for implant components?
Is Criterion certified for medical device manufacturing?
Can Criterion support both prototype and production runs for orthopedic implants?
What documentation does Criterion provide with implant component shipments?
Talk to our engineering and quality team for a no-obligation technical consultation.
Medical device quality management system certification for implantable components.
International quality management system standard ensuring consistent process excellence.
Women's Business Enterprise National Council certified woman-owned business.
Share your part drawings, material specifications, and volume requirements. Our team will respond with a detailed quote and manufacturability feedback within one business day.
For immediate assistance, feel free to give us a direct call at 216-267-1733 You can also send us a quick email at office@criteriontool.com
For immediate assistance, feel free to give us a direct call at 216-267-1733 You can also send us a quick email at office@criteriontool.com