# K100956: Spondy Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Allure Spine LLC
- Decided: Jul 9, 2010 after 93 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: 4 generations back to K000319 (2000). 18 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091725: Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549), U&I Corp. (2009) Summary page 2.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 2.
- K051216: Hydralok System, Altiva Corp. (2005)
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 2.
- K041449: Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction Seat, Interpore Cross Intl. (2004) Summary page 2.

## Most influential descendants
- K111115: Captiva Spine Caplox II Spinal Fixation System (2011), 16 descendants of its own
- K120292: Caplox II Pedicle Screw System (2012), 15 descendants of its own
- K122332: Towerlox Pedicle Screw System (2012), 14 descendants of its own
- K131538: Caplox II Pedicle Screw System/Towerlox Pedicle Screw System (2013), 6 descendants of its own
- K152781: Adena-Zina System (2016), 5 descendants of its own

## Indications for use
The Spond y TM Spinal Fixation System is a posterior, non-cervical pedlicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion. In addition, when used as a pedlicle screw fixation system, the Spondy Spinal Fixation System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K100956
Methodology: https://510kreport.com/methodology