# K102870: Exactech Proliant Polyaxial Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Jan 21, 2011 after 113 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: 10 generations back to K901587 (1990). 57 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051216: Hydralok System, Altiva Corp. (2005) Summary page 1.
- K062670: Vertiflex Spinal Screw System, Vertiflex (Tm), Incorporated (2007) Summary page 1.
- K073245: Extended Vertiflex Spinal Screw System, Vertiflex, Inc. (2008) Summary page 1.

## Most influential descendants
- K151704: Diplomat® Spinal System (2016), 4 descendants of its own
- K191932: Momentum™ Posterior Spinal Fixation System (2019), 2 descendants of its own
- K231809: Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement (2023), 1 descendant of its own
- K141282: PGS 5.5 MM Cannulated Pedicle Screw (2014), 1 descendant of its own
- K251719: Momentum® Posterior Spinal Fixation System (2025), 0 descendants of its own

## Indications for use
The Exactech® Proliant Polyaxial Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the Proliant System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the LS-S1I vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.

Source page: https://510kreport.com/device/K102870
Methodology: https://510kreport.com/methodology