# K133216: Crescent Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Nov 22, 2013 after 35 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). 41 ancestors in all.
92 later devices descend from it; 6 cite it directly.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094025: Crescent Spinal System, Medtronic Sofamor Danek (2010) Summary page 2.
- K110543: Crescent (R) Spinal System Titanium, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 2.

## Most influential descendants
- K210425: Catalyft PL Expandable Interbody System (2021), 56 descendants of its own
- K212524: Anteralign Spinal System with Titan nanoLOCK Surface Technology (2021), 55 descendants of its own
- K214010: Anteralign Spinal System with Titan nanoLOCK Surface Technology (2022), 49 descendants of its own
- K150847: Foundation Interbody Devices (2015), 29 descendants of its own
- K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own

## Indications for use
The CRESCENT® Spinal System is indicated for interbady fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to SI1. These DDD patients may also have up to Grade I 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 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/K133216
Methodology: https://510kreport.com/methodology