# K982987: Synthes Posterior Universal Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: Oct 21, 1998 after 56 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.
226 later devices descend from it; 3 cite it directly.
1 of 227 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K062136: Pass 2 Spinal System (2006), 146 descendants of its own
- K110497: Pass LP Spinal System (2011), 133 descendants of its own
- K123138: Pass LP Spinal System (2013), 132 descendants of its own
- K133350: Revere Stabilization System (2014), 93 descendants of its own
- K142798: PASS LP Spinal System (2015), 84 descendants of its own

## Indications for use
When used < a postertor pedicle screw fixativn system, the Synthes Posterior Universal Spinal System devices are inteuded to provide immobilization and stabilization ot spinal segments in skeletally maturc paticnts as an adjunct to fusion in the treatment of the followiug acute and chronic inetabilities or deformities of the thoracic, lubar, and sacral spine: degenerative spondylolisthesis with objectlve cvidence of ncurologic impairment, fracture, dislocation. scoliosls, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, the Synthes Posterior Universal Spinal Systeu is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L, - S, vertebra in skeletally marure patients recelving fusion by autogenous bone graft having implants attached to the lumbar and sucial spine with removal of the implants after the attainment of a solid fusiun. The levels of pedicle serew fixation for these patients are L3-52. When uced 2s 2 posterior nan-pedicle screw fixation system, Syuties Posterior Universal Spinal System devices are intended for scolivtic, lurdotic, or kyphotic deformities (such as scoliasic. Schuermann’s discusc), degenerative dise disease (back pain of diseogenic origin with degeneration of the disc confirmed by hictory and radiographic studies), and fractures of the pustciior tharacolumbar spine. In addition, when used with the 3.5mm / 6.0mm parallel conncctor, the Synthes Posterior Universal Spinal System can be liitked to the Posterior Cervical/Thoracic Hook/Rod System.

Source page: https://510kreport.com/device/K982987
Methodology: https://510kreport.com/methodology