# K130057: ESPIN

- Pathway: 510(k) (Special)
- Applicant: Nlt Spine, Ltd.
- Decided: Feb 7, 2013 after 29 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: 8 generations back to K991794 (1999). 28 ancestors in all.
1 later device descends from it; 1 cites 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)
- K120553: ESPIN, Nlt Spine, Ltd. (2012) Summary page 1.

## Most influential descendants
- 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 mnature patients with degenerative disc disease (DDD)- DOD is defined as back pain of discogenhc onigin with degeneration of the di confirmed by the history and radiographic studies. DOD patients may also have up to Grade I Spondylolisthesis or retrolisthiesis 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 (ie. posterior pedicle screw and rod systemns).

Source page: https://510kreport.com/device/K130057
Methodology: https://510kreport.com/methodology