CD HORIZON SPINAL SYSTEM

K961633 · Sofamor Danek USA,Inc. · KWP · Dec 5, 1996 · Orthopedic

Device Facts

• Record ID: K961633
• Device Name: CD HORIZON SPINAL SYSTEM
• Applicant: Sofamor Danek USA,Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Dec 5, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CD HORIZON™ Spinal System is intended to provide temporary stabilization and to help augment the development of a solid spinal fusion. Except for situations using pedicle screws in patients, (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass, the specific indications for the CD HORIZON™ Spinal System are the following: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). 2. Pseudoarthrosis 3. Stenosis 4. Spondylolisthesis 5. Spinal deformities: scoliosis, kyphosis, and lordosis 6. Fracture 7. Unsuccessful previous attempts at spinal fusion 8. Tumor resection The CD HORIZON™ Spinal System is intended for use only in the thoracic, lumbar, and/or sacral levels of the posterior spine. The CD HORIZON™ Spinal System is limited to non-cervical use. The CD HORIZON™ Screws, TSRH® Variable Angle Screws, LIBERTY® screws, and/or DYNA-LOK® bolts, when used as pedicle screws with the CD HORIZON™ Spinal System, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. When used for pedicle screw fixation as described above, the screws are indicated only for insertion no higher than L3 and not lower than the sacrum. Otherwise the CD HORIZON* screws, TSRH* Variable Angle Screws, LIBERTY* screws, and/or DYNA-LOK* bolts, when used with the CD HORIZON* Spinal System, are intended for sacral/iliac attachment only. The CCD* Screw for Sacral Block and CCD* Conical Fixation Screws are intended for sacral/iliac attachment only. All of the CD HORIZON* hooks are intended for thoracic and/or lumbar attachment only. GDLH* CROSSLINK* Bars, CD HORIZON* Low Profile CROSSLINK* plates, and TSRH* CROSSLINK* plates are intended for posterior thoracic, lumbar, and/or sacral use only.

Device Story

Spinal rod-based system providing temporary stabilization to facilitate spinal fusion; consists of rods, hooks, screws, bolts, and connectors. Components are rigidly locked into configurations tailored to individual patient anatomy. Used in posterior thoracic, lumbar, and sacral spine. Operated by surgeons in clinical/OR settings. System integrates components from existing Sofamor Danek systems (TSRH, GDLH, LIBERTY, DYNA-LOK) to allow modular construct assembly. Output is a rigid internal fixation construct; provides mechanical support to the spine during the healing process. Benefits patient by maintaining alignment and stability while bone graft matures into solid fusion mass.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Spinal rod-based fixation system; components include rods (5.5mm/6.35mm diameter), hooks, pedicle screws, bolts, and cross-connectors. Materials include stainless steel. Modular design allows integration with existing TSRH, GDLH, LIBERTY, and DYNA-LOK components. Mechanical fixation via rigid locking mechanisms. Non-cervical, posterior application.

Indications for Use

Indicated for patients requiring spinal stabilization to augment fusion. Conditions: degenerative disc disease, pseudoarthrosis, stenosis, spondylolisthesis, spinal deformities (scoliosis, kyphosis, lordosis), fracture, failed prior fusion, tumor resection. Pedicle screw use restricted to severe L5-S1 spondylolisthesis (Grades 3-4) with autogenous bone graft, L3-sacrum levels, and removal after fusion. Non-cervical, posterior thoracic/lumbar/sacral use only.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Reference Devices

• TSRH® Spinal System
• GDLH® Spinal System
• LIBERTY® Spinal System
• DYNA-LOK® Spinal System

Submission Summary (Full Text)

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NOV 26 '96 02:43PM SOFAMOR DANEK

# K961633
## CD HORIZON™ Spinal System
### 510(k) Summary
#### November, 1996

I. **Company:** Sofamor Danek USA
1800 Pyramid Place
Memphis, TN 38132
901-396-3133

DEC - 5 1996

II. **Proprietary Trade Name:** CD HORIZON™ Spinal System

**Classification Name:** Pedicle Screw Fixation - Spondylolisthesis spinal fixation device system. Otherwise, spinal interlaminal fixation orthosis.

III. The CD HORIZON™ Spinal System is a spinal rod based system. The CD HORIZON™ implant components, as well as the stainless steel implant components from the other systems, can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Implant components comprising the CD HORIZON™ and those components from other stainless steel Sofamor Danek spinal systems which can be used with the CD HORIZON™ Spinal System are listed in the following table. Please note that while some implants are identified for use on both size rods, some of these are designed for specific rod diameter.

| Component | 5.5mm Diameter Rod | 6.35mm Diameter Rod |
| --- | --- | --- |
| Rods:
TSRH® Rods | | ☑ |
| GDLH® Rods | ☑ | |
| LIBERTY® Rods | | ☑ |
| CD HORIZON™ Rod | | ☑ |
| Hooks:
CD HORIZON™ Hooks | ☑ | ☑ |
| Screws/Bolts:
CD HORIZON™ Screws
5.5mm, 6.5mm, 7.5mm diameter | ☑ | ☑ |
| TSRH® Variable Angle Screws
5.5mm, 6.5mm, 7.5mm diameter | ☑ | ☑ |
| DYNA-LOK® Bolts
6.5mm, 7.0mm, 7.5mm, 8.5mm diameter | ☑ | ☑ |
| LIBERTY® Screws
Closed-5.5mm, 6.5mm, 7.5mm diameter
Closed w/10° Oblique Canal-6.5mm,
7.5mm diameter
Closed w/15° Oblique Canal-6.5mm,
7.5mm diameter
Open-5.5mm, 6.5mm, 7.5mm diameter | | ☑
☑
☑
☑
☑ |
| CCD™ Screw for Sacral Block, 7.0mm diameter | ☑ | ☑ |
| CCD™ Conical Fixation Screws, 7.0mm diameter | ☑ | ☑ |

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| Component | 5.5mm Diameter Rod | 6.35mm Diameter Rod |
| --- | --- | --- |
| Connectors and Cross Connectors: | | |
| CD HORIZON® DTT No. 4 Connectors | ☑ | ☑ |
| CD HORIZON® Domines | ☑ | ☑ |
| CD HORIZON® Axial Connectors | ☑ | ☑ |
| CD HORIZON® Sacral Fixation Device | ☑ | ☑ |
| CD HORIZON® C-rings | ☑ | ☑ |
| CD HORIZON® Low Profile MULTI-SPAN™ CROSSLINK® Plates | ☑ | ☑ |
| TSRH® Low Profile CROSSLINK® Offset Plates | ☑ | ☑ |
| TSRH® Low Profile CROSSLINK® Plates | ☑ | ☑ |
| TSRH® CROSSLINK® Plates | ☑ | ☑ |
| TSRH® Top Tightening Variable Angle T-Bolts, Variable Angle, and Eyebolt Connectors | ☑ | ☑ |
| TSRH® Lateral Offset Plates | ☑ | ☑ |
| TSRH® Rod/Bolt Connectors | ☑ | ☑ |
| TSRH® Variable Angle Lateral Offset Plates | ☑ | ☑ |
| TSRH® Variable Angle CROSSLINK® Plates | ☑ | ☑ |
| TSRH® Fixed CROSSLINK® Plates | ☑ | ☑ |
| GDLH® CROSSLINK® Bars | ☑ | ☐ |
| GDLH® Rod/Bolt Connectors | ☑ | ☑ |
| LIBERTY® Lateral Connectors | ☐ | ☑ |
| LIBERTY® Open Implant Closure Saddle and Set Screw | ☐ | ☑ |
| CD HORIZON®, GDLH™, and TSRH® Set Screws and Fasteners | ☑ | ☑ |

IV. The CD HORIZON™ Spinal System is intended to provide temporary stabilization and to help augment the development of a solid spinal fusion. Except for situations using pedicle screws in patients, (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass, the specific indications for the CD HORIZON™ Spinal System are the following:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
2. Pseudoarthrosis
3. Stenosis
4. Spondylolisthesis
5. Spinal deformities: scoliosis, kyphosis, and lordosis
6. Fracture
7. Unsuccessful previous attempts at spinal fusion
8. Tumor resection

The CD HORIZON™ Spinal System is intended for use only in the thoracic, lumbar, and/or sacral levels of the posterior spine. The CD HORIZON™ Spinal System is limited to non-cervical use. The CD HORIZON™ Screws, TSRH® Variable Angle Screws, LIBERTY® screws, and/or DYNA-LOK® bolts, when used as pedicle screws with the CD HORIZON™ Spinal System, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. When used for pedicle screw fixation as described above, the screws are indicated

E/E·d

WALI:60 96,22 AON

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NOV 26 '96 04:50PM SOFAMOR DANCK

only for insertion no higher than L3 and not lower than the sacrum. Otherwise the CD HORIZON* screws, TSRH* Variable Angle Screws, LIBERTY* screws, and/or DYNA-LOK* bolts, when used with the CD HORIZON* Spinal System, are intended for sacral/iliac attachment only. The CCD* Screw for Sacral Block and CCD* Conical Fixation Screws are intended for sacral/iliac attachment only. All of the CD HORIZON* hooks are intended for thoracic and/or lumbar attachment only. GDLH* CROSSLINK* Bars, CD HORIZON* Low Profile CROSSLINK* plates, and TSRH* CROSSLINK* plates are intended for posterior thoracic, lumbar, and/or sacral use only.

V. Mechanical test data were supplied in support of the CD HORIZON Spinal System 510(k) notification. The CD HORIZON Spinal System was declared to be substantially equivalent to several commercially available devices.

©1996 Sofamor Danek