# K052123: Synthes Pangea System

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Sep 23, 2005 after 49 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K990745 (1999). 2 ancestors in all.
774 later devices descend from it; 21 cite it directly.
2 of 777 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992739: Click'x, Synthes Spine (2000) Summary page 1.

## Most influential descendants
- K082572: Uss Iliosacral, Uss Polyaxial (2008), 659 descendants of its own
- K091445: CD Horizon Spinal System (2010), 581 descendants of its own
- K082914: Clampfix (2008), 350 descendants of its own
- K090605: Clampfix (2009), 349 descendants of its own
- K103287: Synthes 6.0 Cocr and CPT TI-3 Rods (2011), 348 descendants of its own

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

Source page: https://510kreport.com/device/K052123
Methodology: https://510kreport.com/methodology