# K073320: Cimplicity Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Smith Partners L.P.
- Decided: Feb 7, 2008 after 73 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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 P000028 (2002). 1 ancestor in all.
1,018 later devices descend from it; 2 cite it directly.
1 of 1,020 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P000028: Affinity (TM) Cage System, Medtronic Sofamor Danek USA, Inc. (2002) Summary page 1.

## Most influential descendants
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems (2009), 1,008 descendants of its own
- K101923: Concorde Curve System (2010), 609 descendants of its own
- K110454: Cougar LS Lateral Cage System (2011), 602 descendants of its own
- K101302: Aleutian Ibf System (2010), 595 descendants of its own
- K113348: Cougar System (2011), 591 descendants of its own

## Indications for use
The Cimplicity Spinal Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Cimplicity implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K073320
Methodology: https://510kreport.com/methodology