# K061353: Trinica Anterior Lumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Aug 30, 2006 after 107 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
No predicates in its family tree.
167 later devices descend from it; 4 cite it directly.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Anterior Tension Band (ATB) System: named in the summary without a submission number
- (no number) DePuy Spine AEGIS Anterior Lumbar Plate System: named in the summary without a submission number

## Most influential descendants
- K070922: Modification to Spinal Usa VBR System (2007), 161 descendants of its own
- K091044: Spinal Usa Anterior Lumbar Plate System (2009), 159 descendants of its own
- K082187: Biomet Anterior Lumbar Plate (2008), 126 descendants of its own
- K121791: Zou Anterior Lumbar Plate System (2012), 113 descendants of its own
- K101255: Alphatec Spine Anterior Lumbar Plating System (2010), 113 descendants of its own

## Recalls of this device
- Oct 9, 2013 · Class II · Z-0357-2014: Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.01058.001 (all lots). The Ratchet Handles, part 07.00438.001 may not be effectively sterilized if left 

## Indications for use
The Trinica Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.

Source page: https://510kreport.com/device/K061353
Methodology: https://510kreport.com/methodology