# K072914: Natural Bridge LP Transverse Connectors

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Jan 3, 2008 after 83 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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 K042635 (2005). 4 ancestors in all.
65 later devices descend from it; 7 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052398: Mesa Spinal System, K2m, LLC (2005) Summary page 1.
- K042635: Denali Spine System, K2m, LLC (2005) Summary page 1.
- K052404: Denali Deformity System, K2m, LLC (2006) Summary page 1.
- K052405: Sterling Interferenc Screw HT, Regeneration Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- K120099: Range Spinal System (Mesa and Denali) (2012), 53 descendants of its own
- K120656: Everest Spinal System (2012), 43 descendants of its own
- K132757: Everest Spinal System (2013), 41 descendants of its own
- K121016: Range Spinal System (Mesa and Denali) (2012), 38 descendants of its own
- K130330: Range Spinal System (2013), 36 descendants of its own

## Indications for use
The Range Spinal System is a non-cervical spinal fixation devices intended for posterior, non-pedicle fixation for the following indications: degenerative disc disease ( DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Range Spinal System is also intended for non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. They are also indicated for the treatment of severe spondylolisthesis ( grades 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 ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K072914
Methodology: https://510kreport.com/methodology