← Product Code [KWP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP) · K052123 # SYNTHES PANGEA SYSTEM (K052123) _Synthes (Usa) · KWP · Sep 23, 2005 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K052123 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [KWP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP.md) - **Decision Date:** Sep 23, 2005 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3050 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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](/device/K992739.md)) ## Reference Devices - CerviFix System ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## 510(k) Summary | Name of Firm: | Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 | |-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Contact: | Angela Mikroulis
Spine Regulatory Affairs Specialist
Telephone: 610-719-5718
Facsimile: 610-719-5102 | | Trade Name: | PangeaTMSystem | | Common Name/
Classification Name: | Spinal interlaminal fixation orthosis;
Spinal intervertebral body fixation orthosis;
Pedicle screw spinal system | | Device Product
Code and
Classification: | KWP, KWQ, MNH, MNI, NKB
21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070
CLASS II and Class III | | Predicate: | Click'X (K992739) | | Device Description: | The PangeaTM System is similar to the cleared Click'X (K992739). Both are
components of the Universal Spinal System (USS).

The Pangea System includes polyaxial dual-core screws and a non threaded
quarter turn in design locking cap.

The Synthes Pangea polyaxial screws and locking cap are fabricated from
commercially pure titanium and titanium alloy, conforming to ASTM F67
and ASTM F-1295 respectively. | {1}------------------------------------------------ | Intended Use /
Indications for 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 | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {2}------------------------------------------------ ## 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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 {3}------------------------------------------------ ## 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K052123](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K052123) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com