- Key Medical Material Solutions
- Medical Applications
- Clean - Climate Controlled
Medical Device Manufacturing
EPTAM is an FDA-registered medical machining company with centers of excellence in precision plastic and metal machining, injection and insert molding and assembly and laser capabilities. Collaborating from prototype design to production; the EPTAM team has extensive experience in manufacturing polymer solutions for all types of medical device applications.
Our dedicated facilities are designed exclusively to support the needs of medical OEMs offering a single source solution for precision components through plastics, metals and molding. Our facilities machine medical-grade instruments and implants from a variety of FDA-approved and life-science-grade (LSG) polymer materials (i.e., PEEK Optima®, UHMW and Titanium implants).
With a thorough state-of-the-art "cradle to grave" documentation system, EPTAM has direct traceability of the delivered medical product; the documentation process begins with the pure material selection, complete manufacturing, and packaging through the life of the product.
Uncompromised Quality and No Implant Contamination Risks
Superior Medical Implant Materials
EPTAM understands the critical decision process of material selection when it comes to implantable products. EPTAM engineers will help you determine the best material to meet the thermal, strength, and wear requirements of your implant or medical device, taking into account the orthopedic environment to which it may become exposed.
A large inventory of raw materials used in medical device manufacturing ensures a quick response to customer requirements.
Medical materials include
- Carbon Fiber PEEK
- Propylux® HS2
- Radel® R5500
- SS Stainless Steels, including:
17-4, 303, 304, 316, MP35N, Nitronic 60, and Biodur.
- UHMW-PE - Implantable
- Ultem (Colored)
- 60% Woven Carbon Fiber PEEK
- 30% Chopped Carbon Fiber PEEK
For a complete list of current materials, click here.
Orthopedic Medical Devices
EPTAM Precision Micro-Machining is an ISO 13485:2016 certified, premier orthopedic medical device manufacturer. We partner with customers looking for high quality solutions to their medical machining needs. Our expertise lies in intricate orthopedic components with precise dimensional requirements and critical surface finish / aesthetic requirements.
Our core capabilities of orthopedic medical devices include:
- Cervical Plates
- Lumbar Plates
- Facet Screws
- Pedicle screw systems
- PEEK™ spacers
- Titanium fusion cages
- Intramedullary nails
- Bone Screws
- Hip Stems
- Custom Implants
- Humerus Plates
- Radius Plates
- Trauma Fixation Plates
- Humerus Plates
- Wrist Plates
- Bone Screws
Bone, Cervical, Micro Screws
EPTAM Precision Solutions is a leader in the machining of orthopedic screws for the medical market.
We make use of technologically advanced equipment to create the highest quality medical devices on the market. Our attention to detail, medical device knowledge, and vast experience in CNC and micro machining makes us a world class manufacturer of implantable devices.
When manufacturing cervical pedicle screws, bone screws, micro screws, and other orthopedic screws, we use a variety of high-quality machines including:
- CNC Swiss turning up to 12 axis
- High speed multi-axis milling with up to 5 simultaneous axis'
- CNC turning with live tooling
- Wire EDM 4th axis
- Solid Works™ CAD and Virtual Gibbs™ CAM solid model rendering
Endovascular and Cardiovascular Medical Devices
EPTAM Precision Solutions is a medical device manufacturer capable of machining the complex components needed for cardiovascular or endovascular surgeries and treatments. We use our years of experience and machining capabilities to manufacture intricate, precision parts for original equipment manufacturers (OEMs).
At EPTAM Precision Micro-Machining, we have a state-of-the-art machine shop for manufacturing the intricate components that make implants for cardiovascular medical devices and endovascular devices. Our stringent standards ensure high quality machining using both 5 axis milling and Swiss machining with CAD/CAM design and engineering.
Our core capabilities in endovascular or cardiovascular medical devices include:
- Micro cutters
- Micro housings
- Various micro surgical components
- Trans catheter applications
- Micro delivery and implantable components
- Our core materials for this type of medical machining include:
- Various 300 series stainless steels
Machining for Medical Applications
EPTAM's focus and experience on machining precision medical components gives our customers the confidence of knowing their implants meet specifications and quality requirements each and every time. Our FDA-registered team is aligned with advanced machining technologies and quality systems to deliver the highest quality components for even the most challenging implant medical applications.
An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail or Küntscher nail (without proximal or distal fixation), is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body and are manufactured from Titanium.
PEEK-OPTIMA® Machining for Medical Applications
PEEK-OPTIMA® polymers are used in a wide range of specialty medical applications that require non-metallic, long-term implantation. PEEK-OPTIMA® plastic implants exhibit a superior combination of strength, stiffness, and toughness allowing for implant design versatility. These qualities make it ideal for medical-device and plastic-implant applications.
Implantable PEEK OPTIMA® components are used in surgical procedures including spinal implants, hip, knee, and shoulder implants, pacemakers, shoulder anchors, fusion devices, dental caps, plates, and more.
The implants used for internal fixation are made from stainless steel and Titanium, which are durable and strong. If a joint is to be replaced, rather than fixed, these implants can also be made of cobalt and chrome. Implants are compatible with the body and rarely cause an allergic reaction.
UHMW-PE® Machining for Medical Applications
UHMW-PE® devices need to meet the growing trend toward minimally invasive surgery. Medical devices manufactured with UHMW-PE® allow freedom of design to meet challenges with low profiles, superior abrasion resistance, and flexibility. Due to their superior physical and mechanical properties, cleanliness, and consistency, medically implantable grades of UHMW-PE® have become the materials of choice for articulating surfaces, helping restore a higher quality of life to millions of patients worldwide.
EPTAM Precision Molding offers custom Catheter, Introducer, Dilator and associated Manufacturing Solutions. EPTAM Precision Molding offers a wide variety of services including; DFM, Engineering Support, Prototypes, Secondary Operations and Quality/Documentation Certifications. Our manufacturing capabilities include; Tipping, Welding, Insert and Over molding, Eye-Coring, Catheter Finishing, and Leak Testing Complex Small Parts with Tight Tolerances in our clean room environment.
Clean, Climate-Controlled Medical Manufacturing
7- and 5-axis machining capabilities employ dry-machining techniques that will not contaminate or chemically attack plastic parts.
Cellular Manufacturing Environment
Manufacturing cells and employee specialization deliver consistent quality control, ensure the most efficient work flow, and permit customers' products to run on any number of machines without costly tooling changes.
GUI Workstations throughout the plant combined with barcode technology provide live tracking of all projects.
Sodium-bicarbonate-based micro-blast stations ensure critical components are "Burr Free" at customer delivery. EPTAM's proven experience with the latest machining and deburring techniques ensure burr-free, clean parts to the highest standards.
Whether it is serial numbers, part numbers, text, or customer-supplied-logos, EPTAM's marking capabilities guarantee complete traceability of instruments and implants.
To support our unique manufacturing capabilities, EPTAM is DS/EN ISO:13485:2016 Certified, FDA #3005144609 Registered, has completed a customer 21 CFR audit, and has been customer surveyed and certified to produce polymer implants.
Dedicated Medical Manufacturing Center
- Dedicated enclosed area for medical manufacturing only that is segregated from other manufacturing
- Exclusively for machining of polymer instruments and implantables
- Dry-Machining Technology - no coolants on polymers
- Enhanced Marking Capability - uni-glaze paints, machining and laser
- Dedicated account management and resources for each customer ensure quality requirements are met
- Customer service and engineering are matched from the beginning
- Class 7 clean room Customer service and engineering are matched from the beginning
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