# K143350: Nile Alternative Fixation

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Feb 25, 2015 after 93 days
- Product code: OWI (Bone Fixation Cerclage, Sublaminar)
- Device class: 2
- Regulation: 21 CFR 888.3010
- 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 K950697 (1995). 76 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110348: Universal Clamp Spinal Fixation System, Zimmer Spine (2011) Summary page 4.
- K091190: Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063, Zimmer Spine, Inc. (2009) Summary page 4.
- K081622: Universal Clamp Stainless Steel System, Abbott Spine, Inc. (2008) Summary page 4.
- K060009: Abbott Spine Universal Clamp System, Abbott Spine, Inc. (2006) Summary page 4.
- K133482: Silc Fixation System, Globus Medical, Inc. (2014) Summary page 4.
- K132395: Ligapass, Medicrea International (2013) Summary page 4.
- K112736: Pass LP Spinal, Medicrea International (2012) Summary page 4.
- K121541: Jazz System, Implanet, S.A. (2012) Summary page 4.
- K120099: Range Spinal System (Mesa and Denali), K2m, Inc. (2012) Summary page 4.

## Most influential descendants
- K161332: NILE Proximal Fixation Spinal System (2017), 5 descendants of its own
- K160208: NILE Alternative Fixation Spinal System (2016), 5 descendants of its own
- K222684: XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi (2023), 4 descendants of its own
- K163181: TRANSLACE™ Spinal Tethering System (2017), 2 descendants of its own
- K242361: OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI (2024), 1 descendant of its own

## Indications for use
The NILE Alternative Fixation Spinal System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repait of bone fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions. The NILE Alternative Fixation Spinal System may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants.

Source page: https://510kreport.com/device/K143350
Methodology: https://510kreport.com/methodology