# K962608: Synthes (U.S.a.) Universal Spinal Parallel Connector

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 9, 1996 after 159 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
No predicates in its family tree.
94 later devices descend from it; 1 cites it directly.
0 of 95 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) Texas Scottish Rite Hospital (TSRH) Crosslink Axial Plate: named in the summary without a submission number
- (no number) Cotrel Dubosset (CD) System Domino: named in the summary without a submission number

## Most influential descendants
- K113149: Synthes Uss Connectors (2012), 93 descendants of its own
- K120571: Synthes Uss Connector (2012), 74 descendants of its own
- K133746: Polaris Spinal System (2014), 67 descendants of its own
- K143248: Reform Pedicle Screw System (2014), 30 descendants of its own
- K150856: Reform Pedicle Screw System (2015), 26 descendants of its own

## Indications for use
When used as a pedicle screw system, the Synthes Universal Spinal Parallel Connector is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lunbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion. When used as a nonpedicle screw system, it is also intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schueremann’s disease); degenerauve disk disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; and fractures of the posterior thoracolumbar spine (levels T8-S2). The overall levels of fixation are T8-S2.

Source page: https://510kreport.com/device/K962608
Methodology: https://510kreport.com/methodology