# K072650: Ist Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Spinal Technologies, Inc.
- Decided: Nov 28, 2007 after 70 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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 K926453 (1993). 4 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041469: Anterior Compact System, X-Spine Systems (2004) Summary page 1.
- K926453: Synthes (U.S.a.) Anterior Cervical Vertebrae Plate, Synthes (Usa) (1993) Summary page 1.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 1.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- K160604: Cure™ Anterior Cervical Plate (ACP) System (2016), 3 descendants of its own
- K182489: 4CIS® Pinehurst Anterior Cervical Plate system (2019), 1 descendant of its own
- K181543: Cure™ OPEL-C Plate System (2018), 1 descendant of its own
- K153042: TRYPTIK2C-plate Anterior Cervical Plate System (2016), 1 descendant of its own
- K223321: Omnia Medical Coupler-C Anterior Cervical Plate (2023), 0 descendants of its own

## Indications for use
The IST Anterior Cervical Plate is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: * Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) * Spondylolisthesis * Trauma (i.e., fractures or dislocations) * Tumors * Deformity (defined as kyphosis, lordosis, or scoliosis) * Pseudoarthrosis * Failed previous fusions

Source page: https://510kreport.com/device/K072650
Methodology: https://510kreport.com/methodology