# K133402: K2M Modular Hooks

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Jul 30, 2014 after 266 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: 18 generations back to K853033 (1985). 316 ancestors in all.
No later device cites it as a predicate yet.
0 of 317 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052398: Mesa Spinal System, K2m, LLC (2005) Summary page 1.
- K080611: Mesa Spinal System, K2m, Inc. (2009) Summary page 1.
- K141147: Range Spinal System, K2m, Inc. (2014). Cleared while this submission was under review Summary page 1.
- K962708: Titanium CD Horizon Spinal System, Sofamor Danek USA,Inc. (1997) Summary page 1.
- K031655: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2003) Summary page 1.

## Indications for use
RANGE/DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: 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); spondylol isthles is; trauma (i.e.. fracture or dislocation): spinal stenIosis; 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 Range Spinal System may also be used for the same indications as an adjunct to fusion. Except for the ARI staples. the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior nonicervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allografi. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K133402
Methodology: https://510kreport.com/methodology