# K110543: Crescent (R) Spinal System Titanium

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Aug 9, 2011 after 165 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). 40 ancestors in all.
808 later devices descend from it; 7 cite it directly.
1 of 849 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094025: Crescent Spinal System, Medtronic Sofamor Danek (2010) Summary page 2.
- K100175: Clydesdale Spinal System, Medtronic Sofamor Danek (2010) Summary page 2.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 2.

## Cited in the summary but kept off the family tree
- P9710015: LT-CAGE® Titanium Lumbar Tapered Fusion Device. Number could not be read Summary page 2.

## Most influential descendants
- K121760: Capstone Spinal System (2012), 723 descendants of its own
- K123027: Capstone (R) Spinal System (2013), 709 descendants of its own
- K121683: Acculif TL Cage (2012), 682 descendants of its own
- K123752: Acculif TL and PL Cage (2013), 676 descendants of its own
- K132505: Acculif TL and PL Cage (2013), 645 descendants of its own

## Indications for use
The CRESCENT® Spinal System Titanium is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K110543
Methodology: https://510kreport.com/methodology