# K111940: S 100 Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Renovis Surgical Technologies, LLC
- Decided: May 15, 2012 after 312 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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: 7 generations back to K950697 (1995). 25 ancestors in all.
19 later devices descend from it; 7 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042673: Zodiac Polyaxial Spinal Fixation System, Alphatec/Nexmed (2004) Summary page 1.
- K071371: Copa Amd Antimicrobial Wound Dressing, Tyco Healthcare Group LP (2007) Summary page 1.
- K083393: Xia 3 Spinal System, Stryker Spine (2009) Summary page 1.
- (no number) Renovis S 100 Pedicle Screw System: named in the summary without a submission number

## Most influential descendants
- K162764: Jazz Frame System (2017), 6 descendants of its own
- K170730: JAZZ System, including JAZZ Band (2017), 5 descendants of its own
- K222097: OLYMPIC Deformity Band System (2023), 3 descendants of its own
- K173180: Mega Plus Spine System (2018), 3 descendants of its own
- K231694: MASADA Modular Spinal Fixation System (2023), 2 descendants of its own

## Indications for use
The Renovis S 100 Pedlicle Screw 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 thoracic, lumbar, and sacral spine: failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors or trauma (fracture and dislocation). When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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/K111940
Methodology: https://510kreport.com/methodology