# K121482: Instrument System for Endoscopic Spinal Surgery

- Pathway: 510(k) (Traditional)
- Applicant: Theken Spine, LLC
- Decided: Aug 28, 2012 after 102 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
Longest line of descent: 5 generations back to K991794 (1999). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090132: Maxmorespine Spinal System, Hoogland Spine Products, GmbH (2009) Summary page 1.
- K051827: Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys Laminoscope/Multiscope, Joimax GmbH (2005)

## Indications for use
The Instrument System for Endoscopic Spinal Surgery is intended for use in spinal surgical procedures such as: arthroplasty, nucleotomy, discectomy, and foraminotomy. These manual surgical instruments are hand-held devices intended to manipulate tissue in spinal surgery. The rongeurs are manually operated instruments indicated for cuffing or biting bone during surgery involving the spinal column.

Source page: https://510kreport.com/device/K121482
Methodology: https://510kreport.com/methodology