# K992739: Click'x

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: Feb 8, 2000 after 176 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990745 (1999). 1 ancestor in all.
912 later devices descend from it; 21 cite it directly.
2 of 914 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990745: Modification to Synthes Universal Spinal System, Synthes Spine (1999) Summary page 1.

## Most influential descendants
- K052123: Synthes Pangea System (2005), 774 descendants of its own
- K082572: Uss Iliosacral, Uss Polyaxial (2008), 659 descendants of its own
- K091445: CD Horizon Spinal System (2010), 581 descendants of its own
- K040442: Protex Stabilization System (2004), 551 descendants of its own
- K052069: Protex Stabilization System with Additional Componentes (2005), 549 descendants of its own

## Recalls of this device
- Jan 11, 2013 · Class II · Z-0938-2013: Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.

## Indications for use
Posterior Components When used as a posterior pedicle screw fixation system, the Synthes USS is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). In addition, the Synthes USS is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2. When used as a posterior non-pedicle screw fixation system, the Synthes USS is intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schuermann’s disease), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar spine. The Click’X components of the Synthes USS, when used as a posterior pedicle screw fixation system, are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal tumor and failed previous fusion (pseudoarthrosis). In addition, the Click’X components of the Synthes USS are intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-§2. In addition, when used with 3.5/6.0 mm parallel connectors, the Synthes USS can be linked to the CerviFix System. Anterior Components The Anterior Components of the USS are intended for anterolateral screw and/or staple fixation for the correction of anterolateral lordotic deformities for the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine (levels T8-LS5).

Source page: https://510kreport.com/device/K992739
Methodology: https://510kreport.com/methodology