# K121254: Camber Spine Technologies TLS 5.0 Inerbody Cage

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: Jan 11, 2013 after 261 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: 11 generations back to K841189 (1984). 51 ancestors in all.
40 later devices descend from it; 5 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073440: Foundation Cage, Corelink, LLC (2008) Summary page 2.
- K093704: Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 2.
- K113138: Aleutian System, K2m, Inc. (2012) Summary page 2.

## Most influential descendants
- K134038: Camber Spine Diagon Oblique Cage (2014), 28 descendants of its own
- K172064: Ti-Diagon Oblique TLIF (2017), 27 descendants of its own
- K212904: SeaSpine WaveForm C Interbody System (2021), 15 descendants of its own
- K213420: WaveForm L System, WaveForm TO System, WaveForm TA System (2022), 11 descendants of its own
- K222732: WaveForm A Interbody System (2022), 9 descendants of its own

## Indications for use
The Camber Spine Technologies TLS 5.0 Interbody Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DOD) of the lumbar spine at one or two contiguous levels from LZ-S1. ODD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Camber Spine Technologies TLS 5.0 Interbody Cage isto be used with autologous bone graft and implanted via an open transforamninal or posterior approach. Camber Spine Technologies TLS 5.0 Interbody Cage implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K121254
Methodology: https://510kreport.com/methodology