# K070681: Next Generation Anterior Cervical Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: May 4, 2007 after 53 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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: 3 generations back to K971730 (1997). 5 ancestors in all.
62 later devices descend from it; 2 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 2.
- K042317: Cervical Plate, Scient'X (2004) Summary page 2.

## Most influential descendants
- K102820: Appliance, Fixation, Spinal Intervertebral Body (2010), 38 descendants of its own
- K112533: Zavation Cervical Plate System (2011), 26 descendants of its own
- K163104: Terrace™ Anterior Cervical Plate System (2017), 18 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own
- K130030: Zavation Cervical Plate System (2013), 15 descendants of its own

## Recalls of this device
- Aug 25, 2009 · Not classified · Z-1746-2010: The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaging label indicates that the part number of the lot is 61002-026, which corresponds t

## Indications for use
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients. The NEXT GENERATIONTM Anterior Cervical Plate system is intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions: • degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) · spondylolisthesis * trauma (i.e., fracture or dislocation) · spinal stenosis * pseudoarthrosis * tumor * and failed previous fusion.

Source page: https://510kreport.com/device/K070681
Methodology: https://510kreport.com/methodology