# K051216: Hydralok System

- Pathway: 510(k) (Traditional)
- Applicant: Altiva Corp.
- Decided: Jul 19, 2005 after 68 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
29 later devices descend from it; 3 cite it directly.
0 of 30 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 no predicate by number.

## Most influential descendants
- K100956: Spondy Spinal Fixation System (2010), 17 descendants of its own
- 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
- K102870: Exactech Proliant Polyaxial Pedicle Screw System (2011), 9 descendants of its own

## Recalls of this device
- Mar 6, 2009 · Class II · Z-2059-2015: Incorrect thread form on the screw.

## Indications for use
The HydraLok 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: • 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 HydraLok System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 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/K051216
Methodology: https://510kreport.com/methodology