501(K) Spinal Device Approvals

Congratulations to companies who received 510(K) approval this November. Modern Grinding is going to try and list smaller companies who receive approval for spine devices on a monthly basis as a means to provide a view into the newest and latest products on the market:

Product: SPECTRUM SPINE SPINOUS PROCESS DEVICE
Company: SPECTRUM SPINE
Company/Product Description: If you have neck or back pain, you’ve come to the right place. Our Physical Therapists are experts in diagnosing and rehabilitating spinal injuries. We specialize in pre and post surgical rehabilitation, neck and back injuries, and chronic pain.

Product: INTEGRITY SPINE CORE SYSTEM
Company: Integrity Spine
Company/Product Description: Integrity Spine is a medical device company focused on advancing the products and technologies used in spinal procedures.

Product: INTEGRA FACET FIXATION SYSTEM
Company: Seaspine, Inc.
Company/Product Description:

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery.

Integra’s orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.

Product: APEX SPINE SYSTEM
Company: SPINECRAFT LLC
Company/Product Description: The APEX Spine System is comprised of implants and instruments for stabilization of the spine during fusion in the thoracic, lumbar and sacral regions.

Product: SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
Company: SPINEFRONTIER, INC.
Company/Product Description: We combine the experience of surgeons with the ingenuity of engineers to design and develop devices and instruments for spinal fusion and less exposure surgery (LES). Our founding surgeons are involved in every step of the product development cycle, collaborating with our innovation team to create intelligent solutions.

Product: ZIP MIS INTERSPINOUS FUSION SYSTEM
Company: AURORA SPINE
Company/Product Description: The ZIP features articulating bone anchors, a one-step locking mechanism with no set screw and a large graft space designed for biologic material. It is designed for stabilization during T1-S1 lumbar fusion procedures, specifically for the treatment of degenerative disc disease, spondylolisthesis, spinal tumors and trauma. The ZIP is available in various sizes to accommodate different patient anatomy.

Product: ESPIN SYSTEM
Company: NLT SPINE LTD
Company/Product Description: NLT SPINE specializes in the development of innovative spine surgery instrumentation and implants for treating degenerative spinal conditions through small surgical incisions. The company’s vision is to improve patient care and reduce total treatment costs by ultimately shifting from traditional open surgical routines to MISS, employing new methods and technologies to enhance usability and outcomes.

Led by top international leaders in spinal surgery, NLT SPINE holds a wide portfolio of pending and issued patents that cover the non-linear core technology and related implant and instrument technologies.

Product: PASS LP SPINAL SYSTEM
Company: MEDICREA INTERNATIONAL
Company/Product Description: Marketed for the treatment of spinal pathologies (scoliosis, spondylolythesis, traum..) , the PASS LP® thoraco-lumbar fixation system allows to connect the rod at distance from the spine and to perform a 3D correction through progressive stress distribution on all anchorages thanks to the ST2R technique (Simultaneous Translation on 2 Rods).

Product: ANAX 5.5 SPINAL SYSTEM
Company: U & I CORPORATION
Company/Product Description:  The ANAX 5.5 Spinal System is a top-loading multiple component, posterior spinal fixation system which consist of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The ANAX 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

– Top loading for easy introduction of 5.5 mm diameter rod
– A low-profile polyaxial screw head
– Rounded screw head allowing up to 65degrees of angulation
– Double-lead threaded screw for its fast insertion
– No complication but efficiency self tap of the screw
– No cross threading of the set screw
– Rod available in titanium and cobalt chromium (CoCr)

Product: TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
Company: CORELINK LLC
Company/Product Description:  CoreLink designs and manufactures precision surgical instruments and implants with a single goal: to deliver the highest quality products to enable surgeons to provide the best possible outcomes.

Trocar Tip Angle Grinding (Troubleshooting)

We are currently in the middle of a medical device project which involves grinding a standard 15 degree trocar tip on 1.1mm stainless steel wire (316LVM) K-wire. We are having issues with a burr along one edge of the trocar tip. We noticed this burr early on and we have been troubleshooting it. I wanted to make this post in case it could help other manufacturers who are troubleshooting grinding problems.

The standard trocar tip angle we see is 15 degrees. The 15 degrees is measured from the angle of one face of the tip against the center line of the wire.  We have done 8 degree angles for sharper tools and 45 degree angles for a less sharp tools. If you are looking at the end of the wire, the trocar tip is divided into 3 – 120 degree angles. 

The Program
We set up our program to start by grinding off the tip. We grind off about .005″ of material at the edge of the wire. We can only do this on projects in which the wire is larger than the final product and we have excess material that we can waste. Having excess material also allows us to use a sensor for automatically loading the wire. If we don’t have any access wire to use, it is difficult to use the sensor because the leading tip may not be precise.

One Pass at the Tip
We started out our grinding program just taking one pass at the tip i.e. grinding all three tips of the trocar in a single pass along the grinding wheel. This is when we first noticed the burr. We have done grinds in the past and only done a single pass and we had no problems.
Verdict: Did not work

Where does the burr come from?
The edge burr is coming from stainless steel material getting pushed to the side during the grind process and having no where to go. It pushes out over the angle of and offset trocar angle.

Slow down the Grind
For the next attempt, we tried to slow down the grind. We kept with a single pass. Our hope was that by slowing down the grind it would give the material more time to be ground away instead of getting pushed aside.
Verdict: Did not work

Two passes at the Tip
For the next attempt, we kept the grind slowed down and we added a second run across each face of the trocar tip. Our hope was that the second run across the tips would help clear away the burr from the first grind.
Verdict: Helped a little, but did not work

Three passes at the Tip
For the next attempt, we kept the grind slowed down and we added a third run across each face of the trocar tip. Our hope was that the second run across the tips would help clear away the burr from the first grind.
Verdict: Helped a little more, byt did not work

Redressing the Wheel
We are using the wheel dress from a previous project which has a radius dressed into the wheel. The plan is to create a dress a square coming out of the wheel, do you think this will help? We will let you know. We have one more project which needs the radius and then we will try it out
Verdict:

If you are having difficulties with a grinding project, don’t hesitate to reach out. It is what we do all day long. Our engineers are available to help.