# K180376: K2M Patient Specific Rods

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Apr 5, 2018 after 52 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: 19 generations back to K853033 (1985). 426 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 429 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140738: Pass LP Spinal System, Medicrea International (2014) Summary page 4.
- K173508: Everest Spinal System, K2m (2018) Summary page 4.
- K171832: Range/Denali/Mesa Spinal System, K2m, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K253545: Vulcan Spinal System (2026), 0 descendants of its own

## Indications for use
The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications: Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the EVEREST Spinal System may also be used for the same indications as an adjunct to fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K180376
Methodology: https://510kreport.com/methodology