# K102090: Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System

- Pathway: 510(k) (Special)
- Applicant: Spine Smith Partners L.P.
- Decided: Sep 30, 2010 after 66 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P950002 (1996). 5 ancestors in all.
473 later devices descend from it; 5 cite it directly.
1 of 479 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090376: Spinesmith Cynch Spinal System, Spine Smith Partners L.P. (2009) Summary page 1.

## Most influential descendants
- 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
- K153495: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System (2016), 189 descendants of its own

## Recalls of this device
- Jul 31, 2013 · Class II · Z-2258-2013: The product has the potential to be laser marked as a Medium when it actually is a Small.

## Indications for use
The Cynch System is indicated for 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 autograft to facilitate fusion. The Cynch System Visualif is a stand-alone device intended to be used with the two bone screws provided and the accompanying anterior cover plate. Should the physician choose to use fewer than the two screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided.

Source page: https://510kreport.com/device/K102090
Methodology: https://510kreport.com/methodology