# K984578: Synergy D2 Spinal Implants

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Cross Intl.
- Decided: Mar 23, 1999 after 90 days
- Product code: MNI (Orthosis, Spinal Pedicle 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
No predicates in its family tree.
29 later devices descend from it; 5 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 its predicate without a number.
- (no number) Interpore Cross International Synergy Interior and Posterior, Stainless Steel and Titanium Spinal Systems: named in the summary without a submission number

## Most influential descendants
- K162061: M.U.S.T. Pedicle Screw System (2016), 15 descendants of its own
- K100757: Tilock Pedicle Screw System (2010), 9 descendants of its own
- K171369: M.U.S.T. MINI Posterior Cervical Screws System (2017), 8 descendants of its own
- K103671: Genesys Spine Tilock System (2011), 8 descendants of its own
- K152039: Genesys Spine TiLock2 Spinal System (2015), 7 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 mcans 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 having the screws fixed or attachcd to the lumbar and sacral spine; (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation arc L3 to S1/Ilium. In addition, the pediclc screw system may also be used to provide immobilization aud stabilization of spinal segments, in skeletally mature patients as an adjunct to fusion in the treatinent 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 turnor, and failed previous fusion (pseudarthrosis). As a posterior, non-pedicle, screw and hook system, and an anterolateral, intcrvertebral body screw system, the specific indications for the Synergy Spinal System are: 1. Degenerative Disc Disease (as defined by 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 fracturc 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 sacraliliac attachment only, and the Synergy™ hooks and transverse copnectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium. For anterior use, the recommended levels of attachnient are: T10 — L3 for the double rod constructs and TS5 — LS for the single rod construct. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35mm diameter rod system 1s to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.

Source page: https://510kreport.com/device/K984578
Methodology: https://510kreport.com/methodology