Designation underscores company’s commitment to building brand, reputation as the trusted surgical solution for single-procedure torque instruments and kits for implant market

January 16, 2013

Newbury Park, CA.—ECA Medical Instruments, the leading designer and manufacturer of single- procedure torque-limiting and fixed-driver surgical instruments and kits for the medical industry and surgeons worldwide,  announced today the company is registered with the U.S. Food and Drug Administration (FDA) as a Class 1 medical device manufacturing company.

The designation underscores ECA’s commitment to its large global customer base of medical implant manufacturers and its confidence to design and manufacture the highest quality single-procedure surgical instruments and kits which are in high demand as healthcare reform and reimbursement measures take hold.   FDA’s Class I definition states all medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and labeled, and have establishment registration and device listing forms on file.    

“FDA registration is an important step in the evolution of ECA’s product development roadmap and demonstrates our commitment to providing our OEM customers with robust, value packed surgical instruments and kit solutions which make them competitive,” said John Nino, ECA’s President and Chief Executive Officer. “We are expanding our operations and capabilities to provide turnkey design to production products and complex procedural kits including sterile ready and sterile-packed products our customers require. The FDA registration shows our pledge to partner with our customers delivering the highest level of quality by design solutions and providing them measurable value,” he said.

ECA makes a complete portfolio of precision torque-limiting and fixed-driver surgical instruments and multi-instrument surgical kits used to secure screws, fasteners and connectors used for cardiac rhythm management (CRM), neuromodulation, cardiovascular and orthopaedic implants.  The company is a principal supplier to major medical implant manufacturers worldwide including developers of pacemakers, defibrillators, ventricle assist devices and essentially every type of orthopaedic implant including spine, small bone, extremities, trauma, cranial-maxillofacial, knee, hip, shoulder and general reconstruction products.    

Sterile-packed disposable torque-limiting and fixed-driver instruments are being rapidly adopted by orthopaedic implant makers to reduce per procedure costs by eliminating recurring operational overhead to support traditional reusable instruments, which require extensive handling, cleaning, inspection and re-sterilization after each use.  Costly and potentially deadly hospital acquired infections (HAI) and surgical site infections (SSI) are also eliminated by adopting sterile single-procedure instruments.  

ECA Medical Instruments provides off-the-shelf as well as modified standard and full custom single-procedure torque-limiting and fixed-driver instruments and kits. The firm’s Rapid Instrument Customization (RIC) program allows OEM implant makers to work in full collaboration with ECA’s design and product development team to create unique instruments and also convert existing reusable instruments and designs to contemporary and cost effective disposable products quickly.  Major surgical instrument product lines are:

·         Precision torque-limiting instruments from 2 oz./in. to 10 Nm (90 lb./in.)

·         Fixed-Driver instruments including new Wick Away® technology products

·         Surgical procedures kits for orthopaedic implants

·         Sterile-ready and sterile-pack solutions

·         Specialty products including inserters, cannulas, kerrisons and cavity carvers and more

ECA surgical instruments and kits may be purchased off-the-shelf for private label or OEMs may work with the ECA design team to collaborate on custom designs and configurations. ECA products are sold direct to OEMs and also via Greatbatch Medical, a global partner. 

ECA Medical Instruments, an American Capital company, was founded in 1979 and located in southern California.  ECA is the industry leader in single-procedure torque-limiting instruments and kits. The company has manufactured and delivered over 20 million precision torque instruments to the world’s leading producers of cardiac rhythm management, neuromodulation, cardiovascular and orthopaedic implants resulting in over 500 million surgical actuations without fail. Every 22 seconds of everyday an ECA torque instrument is used to secure a medical implant—one patient at a time. ECA was recently named Business of the Year 2012 by the Pacific Coast Business Times.  Find out more at our web site at