Genesis Design & Fabrication is a full-service specialty surgical instrument facility that offers start to finish solutions for custom instrument design and fabrication. They have over 13 years of experience working with surgeons and medical companies to design and produce both simple modifications to existing instruments as well as completely new custom instruments. Genesis can seamlessly transition from instrument design to fabrication in their on-site, FDA registered and ISO certified machine shop equipped for CNC machining, welding, and other processes.

1. SPECIALTY SURGICAL INSTRUMENTS

2. GenesisDesign&Fabrication,LLCisafullservice U.S. basedSpecialty
SurgicalInstrumentfacility…
• Genesis was established in 2002 and has built a reputation with the medical community as
the “go-to” resource for quality, quick turnaround specialty instruments.
• Genesis offers start to finish solutions to fulfill the demanding surgeon’s custom instrument
needs. We have 13+ years of instrument design experience and have completed multiple
projects for some of the largest orthopedics companies. Our 3D design capabilities provide
unique visual and technical clarity that can evolve a doctor’s ideas into a computer
viewable 3D model. We work closely with the surgeons and implant manufacturers to
produce a design that will help the surgeons achieve their desired results. Instruments
produced at Genesis range from simple existing instrument modifications, to completely
new instruments designed to our client’s specifications.
• Genesis offers implant manufacturers, surgeons, and hospitals unique time and cost saver
ability. We can seamlessly and immediately transition from design, to fabrication of an
instrument. Our validated fabrication shop is a fully equipped facility that is staffed with
talented technicians. Instruments are crafted with special care and ready for the operating
room. We specialize in the “one of a kind” instruments, customizations to existing
instruments, and short-run production instruments.
• Validated fabrication services offered in-house are: CNC machining, EDM, TIG and Laser
welding as well as Laser Marking.
• Genesis Design & Fabrication is FDA registered and ISO 13485 compliant.

3. ONEOFAKINDCUSTOMS
OPEN HEART VALVE SIZER, TIBIAL PLANER, SHOULDER SUTURE SETTER, HIP VERSION CONTROL, ETC…

4. PROTOTYPES
MOLDS, MEDICAL PLASTICS ETC…

5. PROTOTYPES
DIP MANDRELS, INSTRUMENT CUSTOMIZATION

6. PRODUCTION
SYRINGE STABILIZER, TIBIAL RESECTION GUIDE, HIP BROACH HANDLE, FEMORAL KNEE BALANCER

7. FULLSERVICEFABRICATIONFACILITY
4500 SQ MACHINE SHOP

8. FULLSERVICEFABRICATIONFACILITY
IN-HOUSE LASER MARKING AS WELL AS LASER & TIG WELDING

9. LINE CARD 2016
Fadal CNC mills (working envelope is as follows: 2216 = 22" x 16"):
2216, 3 axis mill
3016, 3 axis mill
3016, 3 axis mill with 7" rotary 4th axis
4020, 3 axis mill
Okuma CNC lathe:
Cadet working envelope = 8" diameter x 10" long
Fanuc Wire EDM:
Working envelope = 10” x 13” x 8H”
In addition to CNC machines, we have manual machines for milling, surface grinding, turning, and sawing. We also have
in-house capabilities for Laser Marking and Laser and TIG welding.*
Programming is by GibbsCAM and we use a current version of SolidWorks for all CAD designs and can CNC program directly
from the CAD model. In addition, our machines are full 3D capable for machining complex parts.
Genesis is registered with the FDA and is ISO 13485 compliant. We have a full time QC department hosting a CMM. Our
QC inspector performs full in-house 1st article qualification and 100% inspection after completing each process, before
sending product to our clients. Our facility uses only approved material suppliers and outside process vendors for heat
treating and plating if required.**
*In-house machining and welding processes have been validated.
** H900 heat treating and Passivation processes have been validated.
We look forward to working with you!!
For any questions please contact:
P 858.513.0077
F 858.513.0078
FDA Registration:
10043117
Steve Carter
CEO
steve@genesisfab.com
or
Daniel Dody
General Manager
dan@genesisfab.com