Complex fixation systems

UNiD™ patient-specific rods

<p>UNiD™ patient-specific rods are designed by the GAiTEWAY™ platform to help achieve alignment goals in spinal surgeries.</p>

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Indications, Safety, and WarningsCD Horizon™ system indicationsThe CD Horizon™ spinal system with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ spinal system titanium, cobalt chrome, and stainless-steel implants may also be used for the same indications as an adjunct to fusion.With the exception of DDD, the CD Horizon™ Legacy™ 3.5 mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5 mm rods may be used for the specific pediatric indications noted below.When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ spinal system titanium, cobalt chrome, and stainless-steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ spinal system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1–2 level use in the lumbosacral spine (L2–S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.In order to achieve additional levels of fixation, the CD Horizon™ spinal system rods may be connected to the Vertex™ reconstruction system with the Vertex™ rod connector. Refer to the Vertex™ reconstruction system package insert for a list of the Vertex™ indications of use.RisksAll of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of potential adverse events includes:

Disassembly, bending, or breakage of any or all of the components

Early or late loosening of any or all of the components

Disassembly, bending, or breakage of any or all of the components

Post-operative change in spinal curvature, loss of correction, height, or reduction

Infection

PASS LP™ system descriptionThe internal fixation devices are composed of screws, hooks, rods, plates, cross links, connection and locking devices .The range of different sizes and shapes of the implants allows the surgeon to adapt to the pathology and morphology of each of his patients. The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, with the exception of the rods intended for in situ bending which are manufactured in non-alloyed titanium (CP titanium) conforming to ISO 5832-2 specifications and ASTM F67 specifications and the CoCr rods which are manufactured in cobalt chrome alloy Co-Cr28Mo6 conforming to ISO 5832-12 specifications and ASTM F1537 specifications. The patient-specific rod has been designed and manufactured for one specific patient. The patient-specific rod should be used during surgery for this patient only and should not be reused (single use only). Refer to the surgical technique brochure for additional information. If this patient-specific rod does not perform as intended, use the standard PASS LP rod to complete the surgery. Under no circumstances are the implants reusable.IndicationsThe PASS LP™ spinal systems include a pedicle system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine:

Fractures

Dislocation

Failed previous fusion (pseudarthrosis)

Spinal stenosis

Degenerative spondylolisthesis with objective evidence of neurological impairment

Spinal deformations such as scoliosis or kyphosis

Loss of stability due to tumors

The PASS LP™ spinal systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5–S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.The PASS LP™ also include hooks and rods and sacral/iliac screws indicated for degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis and failed previous fusion.Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP™ spinal system implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP™ spinal system is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.Warning: The safety and effectiveness of this device has not been established for use as part of a growing rod construct. This device is only intended to be used when definitive fusion is being performed at all instrumented levels.RisksIn addition to the risks associated with surgery of the spine without instrumentation, a number of possible undesirable effects may occur with instrumented surgery (including but not limited to):

Detachment, deformation, mobilization, slipping, breakage of one or all of the components

Pain due to the surgery, the fracture, deformation and or migration of an implant

Fracture of the pedicle during insertion of a pedicular screw

Postoperative loss of correction and/or reduction of the spine, partial or total loss of the corrections achieved

UNiD™ spine analyzer indicationsThe UNiD™ spine analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

Features


Thoracolumbar
Single diameter: Ø4.75 mm Ø5.5 mm Ø6.0 mm Dual diameter: Ø4.75 mm to Ø5.5 mm Ø4.75 mm to Ø6.0 mm Ø5.5 mm to Ø6.0 mm
Materials Titanium alloy Cobalt chrome (CoCr)

Thoracolumbar

Single diameter:

Ø4.75 mm
Ø5.5 mm
Ø6.0 mm

Dual diameter:

Ø4.75 mm to Ø5.5 mm
Ø4.75 mm to Ø6.0 mm
Ø5.5 mm to Ø6.0 mm

Materials

Titanium alloy
Cobalt chrome (CoCr)


Cervico-Thoracic
Single diameter: Ø3.5 mm Dual diameter: Ø3.5 mm to Ø4.75 mm Ø3.5 mm to Ø5.5 mm Ø3.5 mm to Ø6.0 mm
Materials Titanium alloy Cobalt chrome (CoCr)

Cervico-Thoracic

Single diameter:

Ø3.5 mm

Dual diameter:

Ø3.5 mm to Ø4.75 mm
Ø3.5 mm to Ø5.5 mm
Ø3.5 mm to Ø6.0 mm

Materials

Titanium alloy
Cobalt chrome (CoCr)


Degenerative
Single diameter: Ø4.75 mm Ø5.5 mm Ø6.0 mm
Materials Titanium alloy Cobalt chrome (CoCr)
Options MIS (Ø4.75 mm, Ø5.5 mm, & Ø6.0 mm)

Degenerative

Single diameter:

Ø4.75 mm
Ø5.5 mm
Ø6.0 mm

Materials

Titanium alloy
Cobalt chrome (CoCr)

Options

MIS (Ø4.75 mm, Ø5.5 mm, & Ø6.0 mm)


Pediatric
Single diameter: Ø3.5 mm Ø4.75 mm Ø5.5/6.0 mm
Materials Titanium alloy Cobalt chrome (CoCr)
Options D-ROD (Ø6.0 mm ONLY)

Pediatric

Single diameter:

Ø3.5 mm
Ø4.75 mm
Ø5.5/6.0 mm

Materials

Titanium alloy
Cobalt chrome (CoCr)

Options

D-ROD (Ø6.0 mm ONLY)

Workflow

GAiTEWAY™ plan

Available through the GAiTEWAY™ software platform, you can request concierge surgical plans from an AiBLE™ Clinic engineer. These plans use AI-driven predictive modeling to support more informed decision-making.

Engineer

UNiD™ rod execution  

Create patient-specific rods precisely manufactured to the approved surgical plan, ensuring alignment between planning and intraoperative execution.

UNiD™ is an adaptive spine intelligence system that creates patient-specific rods for spinal alignment correction.

GAiTEWAY™ analysis

Access on-demand post-operative analytics through the GAiTEWAY™ platform to review outcomes, identify trends, and continuously inform future planning.

The GAiTEWAY™ software platform integrates with UNiD™ ASI for pre-operative planning.

Learn about the GAiTEWAY™ software platform

Clinical evidence

UNiD™ rods are associated with lower incidence of rod fracture.¹

Evaluation of postoperative data indicates a reduction in the rod fracture rate.¹

In adult deformity cases (greater than five levels) at least one year after surgery, UNiD™ rods had a fracture rate of 10 out of 453 patients (2.2%). In a subset of International Spine Study Group (ISSG) data with the same parameters, 18 out of 200 (9%) of adult deformity patients experienced rod fractures.^1,2

When patients from the same two studies underwent a pedicle subtraction osteotomy (PSO) in the procedure, the rate is reduced by 79% when using UNiD™ rods, an improvement over the 22% rod fracture rate associated with procedures involving a PSO.^1,2

Rod fracture rates in adult deformity cases

9% 18 out of 200 patients Historic ISSG data

2.2% 10 out of 453 patients UNiD™ patient-specific rod data¹

Rod fractures rate in cases involving a PSO

22% 11 out of 50 patients Historic ISGG data

4.7% 6 out of 127 patients UNiD™ patient-specific rod data¹

Sagittal alignment is the most dominant radiographic predictor of patient outcomes.^3,4

Achieving harmonious alignment of key spinopelvic parameters, such as the sagittal vertical axis (SVA), pelvic incidence/lumbar lordosis mismatch (PI-LL), and pelvic tilt (PT), is a key goal of spinal deformity surgery.⁵ 

 Patients possessing postoperative spinopelvic parameters within normative ranges exhibit improved patient outcomes scores.^2,3

Patient-specific alignment makes a difference. 

These radiographs show sagittal alignment before and after UNiD™ ASI surgery.

Rod-bending with templates yields better accuracy.

In a study by Sardi et al., ten experienced surgeons were asked to contour rods using a French bender to 40, 60, and 80 degrees.⁶

 Without a template, surgeons overbent by a mean of 17.5 to 20.2 degrees for each desired angle, but with a template, they came within an average of two degrees of their target angle. 

Average distance from target angle

Graph depicting that without a template, surgeons overbent by a mean of 17.5 to 20.2 degrees for each desired angle, but with a template, they came within an average of two degrees of their target angle.

UNiD™ patient-specific rods are a part of the AiBLE™ ecosystem.

Discover the AiBLE™ smart ecosystem

Resources

UNID™ ASI Clinical Brief (open in new window)

This clinical brief provides an overview of the clinical rationale, components, and clinical applications of UNiD™ adaptive spine intelligence (ASI).

CLINICAL EVIDENCE PDF 5 MB

UNiD™ patient-specific rods