# K133126: K7 Lumbar Spacers

- Pathway: 510(k) (Traditional)
- Applicant: K7, LLC
- Decided: Dec 9, 2013 after 70 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 12 generations back to K841189 (1984). 82 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K090899: Depuy Spine Lateral System, Depuy Spine, Inc. (2009) Summary page 1.
- K110454: Cougar LS Lateral Cage System, Johnson & Johnson (2011) Summary page 1.
- K073669: Oria Natura Spacer, Choicespine, LP (2008) Summary page 1.
- K082698: Aleutian Ibf System, K2m, Inc. (2009) Summary page 1.
- K101302: Aleutian Ibf System, K2m, Inc. (2010) Summary page 1.
- K110843: Aleutian Spacer System, K2m, Inc. (2011) Summary page 1.
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX, Stryker Spine (2008) Summary page 1.
- K082014: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2008) Summary page 1.
- K101051: Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXX, Stryker Spine (2010) Summary page 1.
- K100305: Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and Eturn XX-12 K; Eturn XX-16 K Wher, Icotec (2011) Summary page 1.

## Most influential descendants
- K170243: LOSPA IS TLIF & DLIF Cages (2017), 0 descendants of its own

## Indications for use
The K7 Lumbar Spacers are Indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, In skeletally mature patients who have had six months of non-operative treatment The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DOD) with up to Grade I spondlylolisthesis or retralisthesis. DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device isintended for use with supplemental fixation and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K133126
Methodology: https://510kreport.com/methodology