Swiss Turning
Ideal for small-diameter bone screws and implant fasteners, our multi-axis Swiss turning centers achieve diameters as small as .010" with tolerances down to ±.0002"—critical for orthopedic and spinal screw geometries.
Precision-machined bone screws and implant screws demand tolerances that leave no room for error. Criterion Precision Machining brings over 70 years of manufacturing expertise to every orthopedic and spinal implant component—producing titanium, stainless steel, and specialty alloy screws with tight tolerances down to ±.0002", full ISO 13485 compliance, and production-ready quality from prototype to volume.

From prototype to full production, we deliver precision-machined implant screws in titanium, stainless steel, and specialty alloys.
Ideal for small-diameter bone screws and implant fasteners, our multi-axis Swiss turning centers achieve diameters as small as .010" with tolerances down to ±.0002"—critical for orthopedic and spinal screw geometries.
High-precision CNC turning for cylindrical implant screw blanks and cannulated screw bodies, handling complex geometries in titanium, stainless steel, and PEEK with tight tolerances and smooth surface finishes.
Multi-axis CNC milling for implant screw heads, drive features, and complex screw profiles requiring 3-, 4-, or 5-axis machining to achieve precise hex, torx, or custom drive geometries.
Production-intent prototype runs for bone screws machined on the same equipment and to the same standards as full production orders, enabling seamless scale-up without reprogram or re-qualification.
Comprehensive CMM-based inspection and dimensional reporting using Global Advantage CMM, OASIS optical inspection, and Keyence systems—measuring critical screw dimensions with full documentation and Certificates of Conformance.
Experienced machining of implant-grade titanium (Ti-6Al-4V), 316L stainless steel, cobalt-chrome alloys, and PEEK—materials that meet the demanding biocompatibility and mechanical requirements of FDA-regulated devices.

Design Review and Engineering Consultation
We begin with a thorough review of your implant screw drawings, tolerances, and material specifications. Our team identifies any manufacturability considerations upfront—helping medical device OEMs avoid costly design revisions before a single part is cut.
Material Selection and Procurement
Precision Machining with Swiss and CNC Equipment
In-Process and Final Quality Inspection
Documentation and Delivery
Discover how leading medical device companies rely on Criterion for precision implant screw components.
Decades of medical device machining experience, rigorous quality systems, and a commitment to zero-defect delivery set Criterion apart.
Our ISO 13485 and ISO 9001 certifications ensure every bone screw meets the strictest medical device quality management requirements.
We hold tolerances down to ±.0002" on implant screws—critical for orthopedic and spinal components where dimensional accuracy is non-negotiable.
Founded in 1953 and now in its third generation of ownership, Criterion brings unmatched machining heritage to FDA-regulated medical device manufacturing.
Every implant screw shipment includes a Certificate of Conformance and inspection reports—providing the documentation chain your regulatory submissions require.
Experienced professionals dedicated to precision, quality, and mission-critical manufacturing.

President
As the third-generation owner of Criterion Precision Machining, Tanya DiSalvo leads a woman-owned precision manufacturing company with roots stretching back to 1953. Under her leadership, Criterion has deepened its specialization in medical device components—including bone screws, implant fasteners, and surgical instrument parts—while investing in advanced Swiss turning, multi-axis CNC equipment, and ISO 13485-certified quality systems. Tanya champions a culture where precision is non-negotiable and every component shipped is held to the same standard as a life-critical device demands. Her vision has positioned Criterion as a trusted partner for orthopedic OEMs and medical device manufacturers across the United States who need a machining partner they can count on without exception.

Estimator/Project Manager
Mike Pinchot serves as Estimator and Project Manager at Criterion Precision Machining, bridging the gap between customer requirements and the shop floor for bone screw and implant component projects. He reviews incoming RFQs, evaluates material and machining requirements, and builds production plans that ensure on-time delivery without compromising the tight tolerances required for FDA-regulated implantable devices. Mike's hands-on understanding of Swiss turning, CNC turning, and multi-axis milling capabilities allows him to provide accurate, competitive quotes and realistic lead times. His project management discipline keeps complex medical device machining programs on schedule from prototype through full production volume.

Chief Financial Officer
David Glass is the Chief Financial Officer at Criterion Precision Machining, ensuring the financial health and operational sustainability of the company's precision medical device machining business. His financial stewardship supports strategic investments in advanced machining equipment, quality inspection systems, and compliance infrastructure—all of which directly benefit customers who rely on Criterion for bone screw and implant component production. David's oversight helps maintain competitive pricing and consistent capacity planning, allowing Criterion to deliver on its promises to medical device OEMs requiring reliable, high-volume implant screw manufacturing without disruption.

Quality Manager
Kelly Marflak is the Quality Manager at Criterion Precision Machining, overseeing the company's ISO 13485 and ISO 9001 certified quality management system for all medical device component production, including bone screws and implant fasteners. Kelly manages the company's multi-layered inspection processes—including CMM, OASIS optical inspection, and Keyence measurement systems—ensuring every implant screw meets dimensional and surface finish specifications before leaving the facility. Her role is central to maintaining the documentation, traceability, and compliance records that medical device OEMs and regulatory bodies require, giving customers confidence that every part delivered meets life-critical quality standards.

Internal Systems Manager
Kellyanne Gottschalk manages Criterion's internal systems and operational workflows, including the company's ProShop ERP platform, which provides end-to-end visibility into bone screw and implant component production schedules, job tracking, and quality records. Her work ensures that production data, inspection results, and customer documentation flow seamlessly across the organization—supporting the ISO 13485 compliance requirements that medical device customers depend on. Kellyanne's systems management keeps the shop floor connected and accountable, enabling Criterion to scale from prototype runs to high-volume implant screw production with the same consistency and precision that defines the company's reputation.

Customer Service
Nilda Feliciano is the primary customer service contact at Criterion Precision Machining, serving as the day-to-day liaison for medical device OEMs and orthopedic implant manufacturers who rely on Criterion for bone screw and implant component machining. She coordinates order status updates, manages delivery inquiries, and ensures that customers receive timely, accurate information throughout the production process. Nilda's dedication to responsive communication means that customers—whether submitting a first prototype order or managing a recurring production program—always have a knowledgeable point of contact who understands the urgency and precision requirements of medical device manufacturing.

Office Administrator
Bonnie Paletta serves as Office Administrator at Criterion Precision Machining, supporting the operational backbone of the company's precision medical device manufacturing business. Her administrative coordination ensures that purchasing, supplier documentation, customer records, and compliance files are organized and accessible—a critical function in an ISO 13485-regulated environment where document control is a quality requirement. Bonnie's organizational precision mirrors the machining precision that Criterion brings to every bone screw and implant component order, contributing to the smooth, professional experience that customers have come to expect from a company with over 70 years of manufacturing heritage.
What is a bone screw?
A bone screw is a medical implant fastener used in orthopedic and spinal surgery to fix bone fractures, attach plates and rods to bone, or anchor prosthetic implants. They are precision-machined components designed to meet strict biocompatibility and mechanical performance standards.
What type of metal is used for bone screws?
How are bone screws made?
How long do bone screws last?
What screws are used in orthopedic surgery?
Who makes medical screws?
How much does a medical titanium screw cost?
What certifications should a bone screw machining supplier have?
Speak with our medical device machining experts for technical guidance and a free project consultation.
Medical device quality management system certification for implantable components.
International quality management standard ensuring consistent precision manufacturing.
Women's Business Enterprise certification recognizing woman-owned business status.
Submit your drawings, specifications, or material requirements and our team will respond with a detailed quote. We work with medical device OEMs of all sizes, from prototype quantities to high-volume production runs.
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