# K020457: Axiamed Trans-Sacral Spinal Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Axiamed, Inc.
- Decided: Sep 26, 2002 after 227 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Surgical Dynamics, Inc., 30K Working Channel Scope and instrument kit for Discectomy: 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) The Nucleotome System and Probe Kits.: named in the summary without a submission number
- (no number) Surgical dynamics Discography System: named in the summary without a submission number
- (no number) Sofamor Danek USA, Inc., Micro Endo Instruments: named in the summary without a submission number

## Indications for use
The intended use ofihe AXlAMED Trans-Sacral Spinal Access Dcvice is for minimally invasive access to the anterior portion of the lower spine for thc purpose of assisting in thc treatment of decompression of the lumbar disc or the performance of lumbar discectomy.

Source page: https://510kreport.com/device/K020457
Methodology: https://510kreport.com/methodology