SYNTHES PANGEA SYSTEM

K052123 · Synthes (Usa) · KWP · Sep 23, 2005 · Orthopedic

Device Facts

• Record ID: K052123
• Device Name: SYNTHES PANGEA SYSTEM
• Applicant: Synthes (Usa)
• Product Code: KWP · Orthopedic
• Decision Date: Sep 23, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Synthes USS (including the Click'X®, and USS VAS variable axis components, and Pangea™), Click'X® Monoaxial, Dual-Opening and the Small Stature USS (which includes small stature and pediatric patients) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion. When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct. When used with the 3.5/6.0 mm parallel connectors, the Synthes USS (including the Click'X® and, USS VAS variable axis components, and Pangea™), Click'X® Monoaxial and Dual-Opening USS can be linked to the CerviFix® System. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including the Click'X®, and USS VAS variable axis components, and Pangea™), the Click' X® Monoaxial and Dual-Opening USS Systems. In addition, Synthes USS (including the Click'X®, and USS VAS variable axis components, and Pangea™), Click'X® Monoaxial and the Dual-Opening USS can be interchanged with all USS 6.0 mm rods and transconnectors

Device Story

Pangea System is a spinal fixation orthosis; component of Universal Spinal System (USS). Device consists of polyaxial dual-core screws and non-threaded quarter-turn locking caps. Used by surgeons in clinical settings to provide stabilization of the spine. System integrates with existing USS rods and transconnectors; allows linkage to CerviFix System via parallel connectors. Provides mechanical support to spinal segments to facilitate fusion; benefits patients by correcting deformities and stabilizing unstable spinal segments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Commercially pure titanium (ASTM F67) and titanium alloy (ASTM F1295). Design: Polyaxial dual-core screws, non-threaded quarter-turn locking cap. Connectivity: Mechanical linkage to USS rods, transconnectors, and CerviFix system via parallel connectors.

Indications for Use

Indicated for non-cervical spinal fixation (T1-S2 pedicle, T1-L5 hook, T8-L5 anterolateral) in patients with degenerative disc disease, spondylolisthesis, trauma, deformities (scoliosis, kyphosis, lordosis, Scheuermann's), tumor, stenosis, pseudoarthrosis, or failed fusion. Pedicle screw fixation limited to skeletally mature patients, except for Small Stature USS which includes pediatric patients.

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.

Predicate Devices

• Click'X (K992739)

Reference Devices

• CerviFix System

Submission Summary (Full Text)

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## 510(k) Summary

| Name of Firm: | Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Angela Mikroulis<br>Spine Regulatory Affairs Specialist<br>Telephone: [phone]<br>Facsimile: 610-719-5102 |
| Trade Name: | PangeaTMSystem |
| Common Name/<br>Classification Name: | Spinal interlaminal fixation orthosis;<br>Spinal intervertebral body fixation orthosis;<br>Pedicle screw spinal system |
| Device Product<br>Code and<br>Classification: | KWP, KWQ, MNH, MNI, NKB<br>21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070<br>CLASS II and Class III |
| Predicate: | Click'X (K992739) |
| Device Description: | The PangeaTM System is similar to the cleared Click'X (K992739). Both are<br>components of the Universal Spinal System (USS).<br><br>The Pangea System includes polyaxial dual-core screws and a non threaded<br>quarter turn in design locking cap.<br><br>The Synthes Pangea polyaxial screws and locking cap are fabricated from<br>commercially pure titanium and titanium alloy, conforming to ASTM F67<br>and ASTM F-1295 respectively. |

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| Intended Use /<br>Indications for Use: | The Synthes USS (including the Click'X®, and USS VAS variable axis<br>components, and Pangea™), Click'X® Monoaxial, Dual-Opening and the<br>Small Stature USS (which includes small stature and pediatric patients) are<br>non-cervical spinal fixation devices intended for use as posterior pedicle<br>screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or<br>as a anterolateral fixation system (T8-L5). Pedicle screw fixation is limited<br>to skeletally mature patients with the exception of the Small Stature USS.<br>These devices are indicated for all of the following indications regardless of<br>the intended use: degenerative disc disease (defined as discogenic back pain<br>with degeneration of the disc confirmed by history and radiographic studies),<br>spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or<br>curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's<br>Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.<br><br>When treating patients with Degenerative Disc Disease (DDD), transverse<br>bars are not cleared for use as part of the posterior pedicle screw construct.<br><br>When used with the 3.5/6.0 mm parallel connectors, the Synthes USS<br>(including the Click'X® and, USS VAS variable axis components, and<br>Pangea™), Click'X® Monoaxial and Dual-Opening USS can be linked to<br>the CerviFix® System. In addition, when used with 3.5/5.0 mm parallel<br>connectors, the Synthes Small Stature USS can be linked to the Synthes USS<br>(including the Click'X®, and USS VAS variable axis components, and<br>Pangea™), the Click' X® Monoaxial and Dual-Opening USS Systems.<br><br>In addition, Synthes USS (including the Click'X®, and USS VAS variable<br>axis components, and Pangea™), Click'X® Monoaxial and the Dual-<br>Opening USS can be interchanged with all USS 6.0 mm rods and<br>transconnectors |
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## Page 2 - Ms. Angela Mikroulis

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

K052123 510(k) Number:

Pangea TM Device Name:

The Synthes USS (including the Click'X®, USS VAS variable axis Indications for use: components, and Pangea™), Click'X® Monoaxial, Dual-Opening and the Small Stature USS (which includes small stature and pediatric patients) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5/6.0 mm parallel connectors, the Synthes USS (including the Click' X®, USS VAS variable axis components, and Pangea™), Click'X® Monoaxial and Dual-Opening USS can be linked to the CerviFix® System. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including the Click' X®, USS VAS variable axis components, and Pangea™), the Click'X® Monoaxial and Dual-Opening USS Systems.

In addition. Synthes USS (including the Click'X®, USS VAS variable axis components, and Pangea™), Click' X® Monoaxial and the Dual-Opening USS can be interchanged with all USS 6.0 mm rods and transconnectors.

| Prescription Use | X (Part 21 CFR 801 Subpart D) |
|----------------------|-------------------------------|
| | AND/OR |
| Over-The-Counter Use | (21 CFR 801 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Page 1 of 1

Division of General, Restorative, and Neurological Devices

510(k) Number K052123