# K032891: TRANS1 Trans-Sacral Spinal Access and Preparation Kit

- Pathway: 510(k) (Traditional)
- Applicant: Trans1, Inc.
- Decided: Jan 15, 2004 after 120 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 3 cite it directly.
0 of 14 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) AxiaMed, Inc., Trans-Sacral Spinal Access Device: named in the summary without a submission number
- (no number) Surgical Dynamics, Inc., 30K Working Channel Scope and instrument kit: named in the summary without a submission number
- (no number) Argus Medical Company Laparoscopic Discectomy Instrument System: named in the summary without a submission number
- (no number) Surgical Dynamics, Inc., Nucleotome Tissue Aspirator/Cutter: named in the summary without a submission number
- (no number) Surgical Dynamics, Inc., Nucleotome II Tissue Aspirator/cutter: named in the summary without a submission number
- (no number) Sofamor Danek Mfg., Inc., Danek Tissue Cutting and Removal System: named in the summary without a submission number
- (no number) United States Surgical, Auto Suture Spinal Elevator: named in the summary without a submission number
- (no number) Harrington Spinal Elevator: named in the summary without a submission number
- (no number) Karlin Technology, Inc., Cobb Spinal Elevator: named in the summary without a submission number

## Most influential descendants
- K070293: Benvenue VCF Osteo Coil System (2007), 10 descendants of its own
- K132817: Kiva VCF Treatment System (2014), 9 descendants of its own
- K181262: SpineJack Expansion Kit (2018), 4 descendants of its own
- K202393: SpineJack Expansion Kit (2020), 3 descendants of its own
- K211238: SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement (2021), 2 descendants of its own

## Indications for use
The intended use of the TranS 1 Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of L5-S1 interbody fusion.

Source page: https://510kreport.com/device/K032891
Methodology: https://510kreport.com/methodology