# K052151: Synthes Pangea Monoaxial System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine Co.Lp
- Decided: Dec 7, 2005 after 121 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031175 (2003). 1 ancestor in all.
562 later devices descend from it; 7 cite it directly.
2 of 564 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031175: Click'x Monoaxial Screws and Hooks, Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- K103287: Synthes 6.0 Cocr and CPT TI-3 Rods (2011), 348 descendants of its own
- K100634: Synthes Matrix System (2010), 316 descendants of its own
- K100952: Modification to Synthes Matrix System (2010), 314 descendants of its own
- K081684: Blackstone Pedicle Screw System (2008), 277 descendants of its own
- K113395: Revere 4.5 Stabilization System (2012), 260 descendants of its own

## Indications for use
The Synthes USS (including the Click’X®, USS VAS variable axis components, and Pangea™), Click’ X® Monoaxial, Pangea Monoaxial, Dual-Opening and the Small Stature USS (which inctudes small stature and pediatric patients) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-82), a posterior hook fixation system (T1-L5), or as an 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, Pangea 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 CerviFix System. When used with the 5.0/6.0mm 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, Pangea Monoaxial, and Dual Opening USS Systems. In addition, Synthes USS (including the Click'X, USS VAS variable axis components, and Pangea), Click'X Monoaxial, Pangea Monoaxial and the Dual Opening USS can be interchanged with all USS 6.0mm rods and transconnectors.

Source page: https://510kreport.com/device/K052151
Methodology: https://510kreport.com/methodology