# K133053: Milestone Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Weigao Orthopaedic Device Co., Ltd.
- Decided: Jul 15, 2014 after 291 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: 10 generations back to K841189 (1984). 28 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 2.

## Most influential descendants
- K172828: Double Medical Cage System (2018), 1 descendant of its own
- K253151: Fule Interbody Fusion Cage System (2026), 0 descendants of its own

## Indications for use
The Milestone Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenemative disc disease (DDD) at one or two levels from L2 to SI. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved level. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via transforaminal approach. These implants are to be used with aulogenous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K133053
Methodology: https://510kreport.com/methodology