# K043522: Issys Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Custom Spine, Inc.
- Decided: Jan 14, 2005 after 25 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
46 later devices descend from it; 3 cite it directly.
0 of 47 devices 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) Moss- Miami Spinal System: named in the summary without a submission number
- (no number) Universal Spinal System: named in the summary without a submission number
- (no number) MIA Spinal System: named in the summary without a submission number
- (no number) Optima Spinal System: named in the summary without a submission number

## Most influential descendants
- K070245: Capsure Pedicle Screw System (2007), 42 descendants of its own
- K081228: Capsure PS (R) Spine System (2008), 39 descendants of its own
- K083353: Capsure (R) PS System (2008), 36 descendants of its own
- K100605: Mis System (2010), 33 descendants of its own
- K111115: Captiva Spine Caplox II Spinal Fixation System (2011), 16 descendants of its own

## Indications for use
Custom Spine Issys Pedicle Screw System is used for the following human spine pathologies: * Deformity * Trauma & Tumor When used as pedicle screw fixation system of the non cervical posterior spine (TI-S I) 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 (pseudarthrosis). In addition these systems are indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 and 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

Source page: https://510kreport.com/device/K043522
Methodology: https://510kreport.com/methodology