# K151481: Sahara Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Dec 21, 2015 after 202 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K841189 (1984). 150 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092211: Chesapeake Spinal System, K2m, Inc. (2010) Summary page 4.
- K120031: Chesapeake Spinal System, K2m, Inc. (2012) Summary page 4.
- K142487: Chesapeake Stabilization System, K2m, Inc. (2015) Summary page 4.
- K111294: Santorini Spinal System, K2m, Inc. (2012) Summary page 4.
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 4.
- K100820: Wenzel Spine Varilift Interbody Fusion System, Wenzel Spine (2010) Summary page 4.

## Most influential descendants
- K201585: Monterey AL Interbody System (2020), 4 descendants of its own
- K250072: CONDUIT™ SYNFIX™ Evolution Secured Spacer System (2025), 1 descendant of its own
- K221490: Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer (2023), 1 descendant of its own
- K262061: Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM (2026), 0 descendants of its own
- K252982: CONDUIT™ ZERO-P™ VA Secured Spacer System (2026), 0 descendants of its own

## Indications for use
The SAHARA Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. The hyperlordotic lumbar implants (at angles > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Sahara Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.

Source page: https://510kreport.com/device/K151481
Methodology: https://510kreport.com/methodology