# K111099: Issys LP Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Custom Spine, Inc.
- Decided: May 5, 2011 after 15 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K955348 (1996). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070281: Issys LP Spinal Fixation System, Custom Spine, Inc. (2007) Summary page 1.
- K072866: Issys LP Spinal Fixation System, Custom Spine, Inc. (2007) Summary page 1.
- K933881: Depuy Motech Moss-Miami Spinal System, Depuy, Inc. (1994) Summary page 1.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 1.
- K964024: Depuy Motech Titanium Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 1.
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 1.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 1.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 1.

## Most influential descendants
- K113361: Securis Spinal Fixation (2012), 0 descendants of its own

## Recalls of this device
- Mar 28, 2013 · Class II · Z-1819-2013: On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specificati

## Indications for use
The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows: For pedicular use: When used as pedicle screw fixation system of the non cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass. The ISSYS LP Spinal Fixation System is also intended to provide immobilization and stabilization of the spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion of degenerative disc disease and spondylolisthesis other than severe spondylolisthesis (grade 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurological impairment. When used as non pedicular fixation system: The ISSYS LP Spinal Fixation System, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following: * Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). * Spondylolisthesis * Fracture * Spinal deformities such as scoliosis, kyphosis, lordosis * Tumor * Revision of failed fusion attempts * Pseudoarthrosis * Spinal Stenosis When used in the anterior indication the ISSYS LP Spinal Fixation System is indicated for use in the thoracic and lumbar spine.

Source page: https://510kreport.com/device/K111099
Methodology: https://510kreport.com/methodology