# K120553: ESPIN

- Pathway: 510(k) (Traditional)
- Applicant: Nlt Spine, Ltd.
- Decided: Aug 9, 2012 after 168 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: 7 generations back to K991794 (1999). 27 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110992: Enspire Debrider System, Spine View, Inc. (2011) Summary page 1.

## Most influential descendants
- K130057: ESPIN (2013), 1 descendant of its own
- K133061: Espin System (2013), 0 descendants of its own

## Indications for use
The eSpin is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DOD). DD is defined as back pain of disclagenic origin with degeneration of the disc confirmed by the history and radiographic studies. DOD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).

Source page: https://510kreport.com/device/K120553
Methodology: https://510kreport.com/methodology