# K081952: Synergy Spinal System (6.35 Polaris)

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine
- Decided: Oct 7, 2008 after 90 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: 1 generation back to K041449 (2004). 3 ancestors in all.
255 later devices descend from it; 6 cite it directly.
0 of 259 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061441: Ebi 5.5 Helical Flange Spinal System, Ebi, L.P. (2006)
- K041449: Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction Seat, Interpore Cross Intl. (2004) Summary page 2.
- K061563: Ebi Array Spinal System, Ebi, L.P. (2006) Summary page 2.

## Most influential descendants
- K090523: Polaris Spinal System (2009), 156 descendants of its own
- K090203: 5.5 Helical Flange Spinal System, Polaris Components (2009), 154 descendants of its own
- K100220: Polaris Spinal System (2010), 153 descendants of its own
- K100409: Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System (2010), 144 descendants of its own
- K120291: OP Spine System (2012), 138 descendants of its own

## Indications for use
The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion. The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods. As a pedicle screw system, the Synergy Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to SI/Ilium. In addition, the pedicle screw system may also be used 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are: 1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 2. Idiopathic scoliosis. 3. Kyphotic deformities of the spine. 4. Paralytic scoliosis and/or pelvic obliquity. 5. Lordotic deformities of the spine. 6. Neuromuscular scoliosis associated with pelvic obliquity. 7. Vertebral fracture or dislocation. 8. Tumors. 9. Spondylolisthesis. 10. Stenosis. 11. Pseudarthrosis. 12. Unsuccessful previous attempts at spinal fusion. For posterior, non-pedicle, screw use, the Synergy screws and lateral connectors are intended for sacral/iliac attachment only, and the Synergy hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium. The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery. For anterior use, the recommended levels of attachment are: T10 to L3 for the double rod constructs and T5 to L5 for the single rod constructs. The 4.75mm diameter rod system can be used in single and double rod constructs while the 6.35mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1cm from any major vessel.

Source page: https://510kreport.com/device/K081952
Methodology: https://510kreport.com/methodology