# K071880: Optima ZS Transition Screw

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Oct 5, 2007 after 88 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) OPTIMA ZS Spinal System: named in the summary without a submission number

## Most influential descendants
- K211027: Altus Spine Pedicle Screw System (2022), 2 descendants of its own
- K230766: Altus Spine Monaco Pedicle Screw System (2023), 1 descendant of its own
- K243419: Altus Spine Navigation System (2025), 0 descendants of its own
- K132644: Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa IS Rod- Pre Bent (Standard & BU (2013), 0 descendants of its own

## Indications for use
The OPTIMATM ZS Spinal System is a posterior pedicle screw fixation 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 with removal of implants after the attainment of a solid fusion. In addition, The OPTIMATM ZS Spinal 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 of the vertebral body · Dislocation * Scoliosis * Kyphosis * Spinal tumor * Failed previous fusion (Pseudoarthrosis). When the Zimmer GmbH Dynesys® Spinal System and the OPTIMATMZS Spinal System are used on contiguous levels, they must be used with the Zimmer GmbH ZimmeP DTOTM Implant, rod-cord combination implant, and the OPTIMATm ZS Transition Screw. The indications for use for each level is as specified for each system.

Source page: https://510kreport.com/device/K071880
Methodology: https://510kreport.com/methodology