# K160528: ANATOMIC PEEK PTC Cervical Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Mar 28, 2016 after 32 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: 3 generations back to P980048 (2001). 7 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142264: Valeo C Spacer System, Valeo II C IBF Device, Amedica Corp. (2014) Summary page 4.
- K133653: Anatomic Peek PTC Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.

## Most influential descendants
- K171075: Calix-C Cervical Interbody Spacer (2017), 15 descendants of its own
- K202398: Ti3Z Cervical Interbody System (2021), 9 descendants of its own
- K202305: Zavation IBF System (2020), 9 descendants of its own
- K221049: Zavation VariSync Plate System and VariSync Spacer System (2022), 6 descendants of its own
- K192502: Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus (2020), 4 descendants of its own

## Indications for use
The ANATOMIC PEEK™ PTC Cervical Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ANATOMIC PEEK™ PTC Cervical Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The ANATOMIC PEEK™ PTC Cervical Fusion System is to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K160528
Methodology: https://510kreport.com/methodology