# K090376: Spinesmith Cynch Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Smith Partners L.P.
- Decided: Apr 1, 2009 after 43 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- 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 P950002 (1996). 4 ancestors in all.
476 later devices descend from it; 3 cite it directly.
1 of 481 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 1.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 1.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.

## Most influential descendants
- K102090: Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System (2010), 473 descendants of its own
- K141942: Midline II TI (2014), 459 descendants of its own
- K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti (2015), 368 descendants of its own
- K152475: FORZA PTC Spacer System (2016), 236 descendants of its own
- K151214: ALIF Interfixated System (2015), 220 descendants of its own

## Indications for use
The Cynch System is indicated intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autografi to facilitate fusion.

Source page: https://510kreport.com/device/K090376
Methodology: https://510kreport.com/methodology