# K143576: Exactech Ambassador

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Feb 27, 2015 after 72 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: 4 generations back to K031276 (2003). 10 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071667: Synthes Vectra-One System, Synthes Spine (2007) Summary page 5.
- K042798: C-Tek C-Trun Anterior Cervical Plate System, Interpore Cross Intl. (2004) Summary page 5.
- K070891: Altiva Classic Acp System, Altiva Corp. (2007) Summary page 5.

## Most influential descendants
- K190227: Boomerang™ Anterior Cervical Plate System (2019), 4 descendants of its own
- K243015: Skyway Anterior Cervical Plate System (2024), 2 descendants of its own
- K250486: Skyway Anterior Cervical Plate System (2025), 1 descendant of its own
- K173867: Axis Anterior Cervical Plate System (2018), 1 descendant of its own
- K261451: ZSAlign Cervical Interbody System (2026), 0 descendants of its own

## Recalls of this device
- May 21, 2015 · Class II · Z-2071-2015: Shipped to a single consignee prior to completion of final inspection.

## Indications for use
The Exactech Ambassador™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K143576
Methodology: https://510kreport.com/methodology