# K142498: MAGNIFY and MAGNIFY-S Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Feb 26, 2015 after 174 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 13 generations back to K841189 (1984). 28 ancestors in all.
175 later devices descend from it; 8 cite it directly.
0 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 4.
- K082252: Independence Spacer, Globus Medical, Inc. (2008) Summary page 4.
- K120101: Independence Spacer, Globus Medical, Inc. (2012) Summary page 4.
- K123231: Caliber Spacers, Globus Medical, Inc. (2013) Summary page 4.
- K072970: Patriot Spacers, Globus Medical, Inc. (2008) Summary page 4.
- K122097: Patriot Spacers, Globus Medical, Inc. (2012) Summary page 4.

## Most influential descendants
- K152022: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer (2017), 149 descendants of its own
- K170157: INDEPENDENCE® Spacers (2017), 109 descendants of its own
- K181357: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers (2018), 97 descendants of its own
- K191391: HEDRON Lumbar Spacers (2019), 84 descendants of its own
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS (2017), 83 descendants of its own

## Indications for use
The MAGNIFY™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™ Spacer is to be filled with autogenous bone graft material, and is to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems. The MAGNIFY™-§ Spacer is a stand-alone interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™-S Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws that accompany each implant.

Source page: https://510kreport.com/device/K142498
Methodology: https://510kreport.com/methodology