# K081108: Monopoly Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medical, LLC
- Decided: Jul 14, 2008 after 87 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 4 generations back to K901587 (1990). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems, Cross Medical Products, Inc. (1998) Summary page 2.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 2.
- K053573: GSS Pedicle Screw System, GS Medical Co., Ltd. (2006) Summary page 2.
- K061577: Ovaltwist Pedicle Screw System, Signus Medizintechnik GmbH (2006) Summary page 2.

## Indications for use
The MonoPoly Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine (TI-Si), specifically as follows: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal tumor, and/or (6) failed previous fusion (pseudarthrosis). When used as a non-cervical and non-pedicle screw fixation system, the MonoPoly Pedicle Screw System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) trauma (fracture, dislocation), (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

Source page: https://510kreport.com/device/K081108
Methodology: https://510kreport.com/methodology