# K071857: Delta Spinal Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Jemo Spine, LLC
- Decided: Aug 8, 2007 after 34 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: 3 generations back to K000319 (2000). 5 ancestors in all.
109 later devices descend from it; 5 cite it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020279: Forex Corporation, Optima, Spinal System, Forex Corp. (2002) Summary page 1.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 1.

## Most influential descendants
- K072022: Valeo Pedicle Screw Spinal System (2007), 100 descendants of its own
- K121115: M.U.S.T Pedicle Screw System (2012), 43 descendants of its own
- K151977: icotec Pedicle System (2016), 30 descendants of its own
- K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (2019), 29 descendants of its own
- K132878: M.U.S.T. Extension (2013), 28 descendants of its own

## Indications for use
The Jemo Spine, LLC, DELTA TM, Spinal Fusion System, a posterior spinal fixation device is a pedicle screw system indicated for the 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 (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the Jemo Spine, LLC, DELTA TM , Spinal Fusion System 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). When used as an posterior screw fixation system such as a sacral/iliac screw fixation system, the Jemo Spine, LLC, DELTATM , Spinal Fusion System is indicated for patients with severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

Source page: https://510kreport.com/device/K071857
Methodology: https://510kreport.com/methodology