# K101255: Alphatec Spine Anterior Lumbar Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Jul 21, 2010 after 78 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: 6 generations back to K922543 (1993). 12 ancestors in all.
113 later devices descend from it; 3 cite it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091044: Spinal Usa Anterior Lumbar Plate System, Spinal USA (2009) Summary page 1.
- K043548: Blackstone Unity Anterior Lumbar Plate Fixation System, Blackstone Medical, Inc. (2005) Summary page 1.
- K061229: Unity LX Anterolateral Lumbar Plate Fixation System, Blackstone Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K182746: ATEC ALIF and LLIF Spacer System (2018), 110 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K191311: ATEC Lateral Interbody System (2019), 78 descendants of its own
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own
- K202812: IdentiTi Cervical Standalone Interbody System (2020), 67 descendants of its own

## Indications for use
The Aiphatec Spine Anterior Lumbar Plating System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Alphatec Spine Anterior Lumbar Plating System is intended for anterior lumbar spine (LI -SI) fixation for the following indications: 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies) 2. Pseudloarthrosis 3. Spondylolysis 4. Spondylolisthesis 5. Trauma (i.e., fracture or dislocation) 6. Spinal stenosis 7. Unsuccessful previous fusion surgery 8. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) 9. Tumrne The Aiphatec Spine Anterior Lumbar Plating System is intended to be used with autograft and/or allograft as an adjunct to fusion.

Source page: https://510kreport.com/device/K101255
Methodology: https://510kreport.com/methodology