# K113361: Securis Spinal Fixation

- Pathway: 510(k) (Traditional)
- Applicant: Cumtom Spine
- Decided: Apr 3, 2012 after 141 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K990745 (1999). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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)
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 1.
- K103287: Synthes 6.0 Cocr and CPT TI-3 Rods, Synthes Spine (2011) Summary page 1.
- K070281: Issys LP Spinal Fixation System, Custom Spine, Inc. (2007). Our reading of the summary gave K070821, FDA’s number for Powdered Natural Rubber Latex Examination Gloves (Protein… (Medtexx Manufacturing Sdn. Bhd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “ISSYS LP”.
- K072866: Issys LP Spinal Fixation System, Custom Spine, Inc. (2007) Summary page 1.
- K111099: Issys LP Spinal Fixation System, Custom Spine, Inc. (2011). Our reading of the summary gave K110099, FDA’s number for Proclear Toric XR Soft (Hydrophilic) Contact Lens… (CooperVision, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ISSYS LP”.
- K043522: Issys Pedicle Screw System, Custom Spine, Inc. (2005) Summary page 2.

## Indications for use
The SECURIS Spinal Fixation System is intended for the immobilization and stabilization of the thoraco-lumbar-sacral spine (Ti-Si) as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined by discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and previously failed fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K113361
Methodology: https://510kreport.com/methodology