# K051856: TRANS1 Facet Screws

- Pathway: 510(k) (Traditional)
- Applicant: Trans1 Incorporated
- Decided: Sep 26, 2005 after 80 days
- Product code: MRW (System, Facet Screw Spinal Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953076 (1997). 2 ancestors in all.
45 later devices descend from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003928: Townley Transfacetpedicular Screw Fixation System, Medtronic Sofamor Danek, Inc. (2001) Summary page 2.
- K953076: Townley Facet/Pedicular Screw Plating System, Sofamor Danek USA,Inc. (1997) Summary page 2.

## Most influential descendants
- K073515: TRANS1 Facet Screw (2008), 44 descendants of its own
- K092568: Spartan S3 Facet System (2009), 29 descendants of its own
- K120340: Venus Facet Screw System (2012), 26 descendants of its own
- K163374: ALLY™ Facet Screws (2017), 18 descendants of its own
- K132126: Spectrum Spine Fenestrated Facet Screw System (2013), 11 descendants of its own

## Indications for use
The TranSI® Facet Screws are to be used in conjunction with the TranSI® AxiaLIF M System which includes the TranSI® 3D Axial RodTM, in order to create an anterior/posterior fixation construct as an aid to fusion. The AxiaLIFTM System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIFTM System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor, or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed facet and pedicle screw systems. The facet screws may be implanted using one of two techniques: transfacetpedicular or translaminar. The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the pedicle. Alternatively, the facet screws may be cross inserted from the base of the spinous process into the opposite lamina and across the facet joint into the base of the lower vertebral transverse process.

Source page: https://510kreport.com/device/K051856
Methodology: https://510kreport.com/methodology