# K073515: TRANS1 Facet Screw

- Pathway: 510(k) (Traditional)
- Applicant: Trans1 Incorporated
- Decided: Mar 11, 2008 after 88 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: 2 generations back to K953076 (1997). 3 ancestors in all.
44 later devices descend from it; 11 cite 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)
- K051856: TRANS1 Facet Screws, Trans1 Incorporated (2005) Summary page 1.
- K003928: Townley Transfacetpedicular Screw Fixation System, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K953076: Townley Facet/Pedicular Screw Plating System, Sofamor Danek USA,Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K211855: Ion Facet Screw System (2022), 10 descendants of its own

## Indications for use
The TranS1® Facet Screws are to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construct as an aid to fusion. 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 (usually) at a single level 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. Bone graft must be used for both fixation methods. For both techniques, the system is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

Source page: https://510kreport.com/device/K073515
Methodology: https://510kreport.com/methodology