# K102820: Appliance, Fixation, Spinal Intervertebral Body

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Nov 5, 2010 after 38 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K973854 (1998). 14 ancestors in all.
38 later devices descend from it; 5 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070681: Next Generation Anterior Cervical Plating System, Alphatec Spine, Inc. (2007) Summary page 2.
- K013877: Codman Slim-Loc System, Codman & Shurtleff, Inc. (2001) Summary page 2.
- K061274: Venture Anterior Cervical Plate System, Medtronic Sofamor Danek (2006) Summary page 2.

## Most influential descendants
- K163104: Terrace™ Anterior Cervical Plate System (2017), 18 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own
- K203065: Lumbar Spine Truss System Plating Solution (LSTS-PS) (2021), 9 descendants of its own
- K200995: Insignia™ Anterior Cervical Plate System (2020), 7 descendants of its own
- K213443: Insignia™ Anterior Cervical Plate System (2021), 6 descendants of its own

## Recalls of this device
- Apr 10, 2015 · Class II · Z-1547-2015: During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling Hexalobe S
- May 29, 2012 · Class II · Z-2273-2012: On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721), does not properly fit into the hexalobe screw on th

## 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 Trestle Luxe 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/K102820
Methodology: https://510kreport.com/methodology