# K012871: Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177

- Pathway: 510(k) (Special)
- Applicant: Interpore Cross Intl.
- Decided: Sep 13, 2001 after 17 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- 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 K934429 (1994). 2 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934429: Anterior Spine System, Buckman Co., Inc. (1994) Summary page 1.
- K940631: Cross Medical - Synergy (TM) Spine System, Cross Medical Products, Inc. (1995) Summary page 1.

## Most influential descendants
- K042143: Excella-M Spinal System (2004), 6 descendants of its own
- K071921: Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial Screws) (2007), 5 descendants of its own
- K102248: Excella II Spinal System Model EC2-00 (2010), 4 descendants of its own
- K140238: Excella Iii-D Spinal Deformity System (2014), 3 descendants of its own
- K241276: Vector™ Pedicle Screw System (2024), 1 descendant 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 having the screws fixed or attached 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 are L3 to S1/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 — L3 for the double rod constructs and T5 — L5 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 is 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/K012871
Methodology: https://510kreport.com/methodology