# K130177: Anatomic Peek Cervical Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Sep 23, 2013 after 241 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
No predicates in its family tree.
628 later devices descend from it; 10 cite it directly.
0 of 629 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K111244: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc), Cook, Inc. (2011). Our reading of the summary gave K111244, FDA’s number for Turbo-Ject Peripherally Inserted Central Venous Catheter… (Cook, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ANATOMIC PEEK CERVICAL FUSION SYSTEM”. Kept off the family tree.

## Most influential descendants
- K142264: Valeo C Spacer System, Valeo II C IBF Device (2014), 532 descendants of its own
- K142050: Nuvasive Coroent Small Contoured Interbody System (2014), 449 descendants of its own
- K140921: Coroent Small Interbody System (2014), 444 descendants of its own
- K150362: NuVasive CoRoent Small Interbody System (2015), 441 descendants of its own
- K160125: Cascadia Interbody System (2016), 315 descendants of its own

## Indications for use
The ANATOMIC PEEKTM CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myclopathy with herniated disc and/or osteophyte formation on posterior vertebral endplatcs producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEKTM device is to be used with supplemental fixation. The ANATOMIC PEEK"" CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open anterior approach.

Source page: https://510kreport.com/device/K130177
Methodology: https://510kreport.com/methodology