SpineShape. The dynamic solution for your back. Technical information to System IV DEVELOPED  AND MANUFACTURED IN  SWITZERLAN

SpineShape System IV highlights • Dynamic stabilization of lumbar vertebrae and intervertebral discs through flexible rods In most cases long-lasting pain relief without spinal fusion surgery and without postoperative medication The mobility of the lower spine is preserved Protection of adjacent vertebrae and discs from excessive wear and tear Rods with three levels of flexibility for optimal adaptation to the particular disease pattern • Degenerative diseases Proven and gentle operation • Dynamic stabilization In summary • Lumbar spine (Th12 – S1) • Lateral and medial approaches •

The stepped region of the Varistab™ exhibits a reduced profile to allow for an elastic coupling of the adjacent motion segment. The SpineShape System IV consists of PCU (polycarbonateurethane) rods and titanium pedicle screws.

RODS FLEXIBILITY SCREWS THREAD LENGTH THREAD DIAMETER stepped (Varistab™) stepped (Varistab™) Implants The rods Rods exist in five versions. Straight standard rods are packed with one each and Varistab™ rods with two each. The screws Pedicle screws exist in 17 sizes available in sets packed with two each, including two normal clamp screws. Rods are available as standard version (normal clamp screws) and Varistab™ (long clamp screws

Contraindications HIGHFLEX  LOWFLEX • Lack of or damaged structural tissues (e.g. vertebrae, (Dynamic) stenosis intervertebral discs, facet joints, ligaments etc) Facet joint syndrome / Spondyloarthrosis • Marked idiopathic scoliosis Osteochondrosis Modic Type I or III Discopathy (recurrent disc prolapse / herniation) • Spondylolisthesis > Meyerding grade 1 Late adjacent segment syndrome • Isthmic spondylolisthesis Complement to disc prothesis Osteochondrosis Modic Type II • Bone tumour Degenerative spondylolisthesis (Meyerding <1) • Osteoporosis that could compromise the screw (Degenerative)...

Instruments DESCRIPTION Square pointer Contracting pliers Pedicle screw setter (with thread lock) Distracting pliers Pedicle screw setter (with holding sleeve) Stud bolt adapter DYNESYS Counter torque sleeve Pedicle screw adapter DYNESYS Clamp screw setter Pedicle sounding probe Universal instrument Big universal handle with ratchet Muscle retaining lever Left rod holding pliers with bent ends Right rod holding pliers with bent ends T-Handle with ratchet Benefits • New INI system for faster implantation • New universal instrument • All instruments in one con

Medical conclusion Our philosophy is to bring the spine back to physiological degeneration while maintaining the sagittal balance. • Shorter operation times • Patient doesn’t feel the implant • Faster rehabilitation • Rare events of sacroiliac joint pain Working again. Full-time and pain-free Our average patient is pain-free, takes no or only little medication and enjoys u nlimited walking-time post- peratively. Most patients are able to work full-time o again in their previous professions. Clinical results from patient population treated from 2015 onward The following data originates from two...

STRONG (NSAR) POST-OPERATIVE MEDICATION WALKING TIME AFTER 3 YEARS Pre-/Post-op comparison of patient A slight increase in medication after All patients made a progress s atisfaction regarding level of low back 3 years is hypothesized to result pain from a scale 0-10: 0-3 (excellent or from an increase in activity. good), 3-6 (fair) and >6 (poor).

The first time in 10 years without pain killers Walking without pain for the first time in 10 years Pain completely disappeared Standing upright without pain for the first time in six months After being unable to work as a truck driver for a long time, again pain-free and able to drive A few days after the operation, completely pain-free and back home again I don‘t feel the implant at all After three conventional surgeries I am pain-free for the first time

Rolf Diener was one of the first having been able to manufacture the conical high-strength pedicle screws. SpineSave: The company behind SpineShape Swissness. Precision. Fascination The company SpineSave has dedicated itself to motion preservation implant systems and offers to the urgeon s Stefan Freudiger was among the first who have developed dynamic stabilization systems. SpineShape System IV is the fourth system for which Stefan Freudiger is listed (co-) inventor. solutions, which on one hand are based on proven m ethods and on the other hand are featured with stepwise innovations. Fascination...

Do you have questions regarding SpineShape System IV? Don’t hesitate to get in contact. SpineSave AG Stationsstrasse 66 CH-8424 Embrach T +41 44 866 72 92 [email protected] www.spinesave.com