SurgTech Inc

Features

The SurgTech Interbody System is available in a wide range of sizes with notable design features including:

Features

Adaptive Sizing
Ergonomically Designed Instrumentations
Poly-ether-ether-ketone (PEEK) Material
Optimal Positioning
Axial Canal Design
Bullet Nose Design

The SurgTech Interbody System offers 2 different footprints at 0 degree and 4-degree lordosis. The height of implant ranges from 9-18 mm in 1mm increments. As a result, the system comprised of 80 implants available in a single set, enabling precise anatomic height and lordotic restoration in a variety of patient populations.

The instrumentation system offers a variety of options for sizing, decompression and maneuverability. The PLIF inserter was specifically designed with match the implant and has proven strength under impaction.

The SurgTech Interbody System are manufactured from PEEK Optima that has proven biocompatibility and strength. The material has the following characteristics: Radiolucent for easy monitoring of healing site with X-rays, CT or MRI Bone-like modulus helps minimize stress shielding and stimulate bone healing extremely strong, durable and highly resistant to creep and fatigue.

The implant has two radiographic marker pins at opposing corners of the implant, which provides an easy means of identifying implant position and orientation on radiographic images.

The large axial open architecture is designed to accommodates autogenous bone graft to allow fusion to occur through the spacer.

The bullet nose of the PLIF is ergonomically designed for the ease of insertion, which allows the implants to be inserted into disc with small clearances, while minimizing damage to endplate.

Instruments

A full set of instruments and tools independently developed and produced.

Thoughtful, surgeon-friendly design and modular, space-saving trays help reduce patients' time under anesthesia by making instrument identification and access quick and easy; The design also reduces space needed in the OR and facilitates efficient, effective in-hospital instrument processing. Essential parts of the SIS Instrument Set include:

SIS Device-specific Class II Instruments:
1. PLIF Inserter 2. PLIF Case 3. PLIF Caddy - Rasp Trials
SIS Class I Instruments:

1. PLIF Caddy - Rasp Trials 2. PLIF Trials 3. PLIF Disc Shaver 4. PLIF Graft Compactor (Block & Impactor) 5. PLIF Endplate Curette 6. PLIF Root Retractors 7. PLIF Manipulator 8. PLIF Handle - T - Large Hudson. 9. PLIF Handle - Palm, Impactable - Large Hudson

Instruments

A Full Set of Tools Layer I
A Full Set of Tools Layer II

1. Sterile PLIF Case-Base Detail X 1；2. PLIF Graft Impactor With Impact Plate X 1; 3. PLIF Graft Block X 1; 4. PLIF Curette X 1; 5. PLIF RASP-Straight X 1; 6. PLIF RASP-Angled X 1; 7. PLIF Retractor-root-10mm X 1; 8. PLIF Retrator-root-15mm X 1; 9. PLIF Manipulator X 1; 10. PLIF Inserter-11mm X 2; 11. PLIF-Inserter Shaft X 2.

1. Sterile PLIF Case-Tray Details X 1; 2. T-Handle-1/4 Square QC X 2; 3. PLIF Disc Shaver-9mm X 1; 4. PLIF Disc Shaver-10mm X 1; 5. PLIF Disc Shaver-11mm X 1; 6. PLIF Disc Shaver-12mm X 1; 7. PLIF Disc Shaver-13mm X 1; 8. PLIF Disc Shaver-14mm X 1; 9. PLIF Disc Shaver-15mm X 1; 10. PLIF Disc Shaver-16mm X 1; 11. PLIF Disc Shaver-17mm X 1; 12. PLIF Disc Shaver-18mm X 1; 13. PLIF Trial Caddy 25mm X 1; 14. PLIF Trial Caddy 20mm X 1

Indication

The SurgTech Interbody System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery and may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal levels. These devices are intended to be used with supplemental fixation which has been cleared for use in the lumbar spine (i.e. a posterior pedicle screw and rod system).

1. Thoracic Disc Herniation (TDH); Spinal Stenosis; Degenerative Intervertebral Instability.
2. Postoperative Lumbar Instability Requiring Simultaneous Posterior Pedicle Screw Fixation.
3. Discogenic Low Back Pain (DLBP) with Limited Anterior Surgery.
4. Patients with Lumbar Spondylolisthesis of Various Causes Requiring Simultaneous Decompression and Reduction and Fixation of the Spinal Canal.
5. Thoracolumbar Tuberculosis.
6. Thoracolumbar Fracture.
7. Congenital Deformity of Spine.
8. Developmental Deformity of Spine.