# K170676: HD Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Hd Lifesciences, LLC
- Decided: Jul 13, 2017 after 129 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: 16 generations back to K841189 (1984). 99 ancestors in all.
122 later devices descend from it; 7 cite it directly.
1 of 222 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 5.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 5.
- K160547: Cascadia Interbody System, K2m (2016) Summary page 5.

## Most influential descendants
- K180364: HD LifeSciences Cervical IBFD System (2018), 106 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 descendants of its own
- K192018: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device (2019), 102 descendants of its own
- K191581: Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (2020), 81 descendants of its own
- K201267: Adaptix Interbody System with Titan nanoLOCK Surface Technology (2020), 79 descendants of its own

## Indications for use
The HD Lumbar Interbody System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and allograft bone comprised of cancellous and/or corticocancellous bone.

Source page: https://510kreport.com/device/K170676
Methodology: https://510kreport.com/methodology