# K102293: Caliber Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jan 5, 2011 after 145 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). 20 ancestors in all.
869 later devices descend from it; 31 cite it directly.
1 of 890 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072970: Patriot Spacers, Globus Medical, Inc. (2008) Summary page 1.
- K093242: Patriot Transcontinental Llif Spacer, Globus Medical, Inc. (2009) Summary page 1.
- K080537: L-Varlock, Kiscomedica S.A. (2008) Summary page 1.

## Most influential descendants
- K113465: Acculif TL Cage (2011), 718 descendants of its own
- K113447: Rise Spacer (2012), 691 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
- K123231: Caliber Spacers (2013), 657 descendants of its own

## Indications for use
CALIBER TM Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). ODD 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). CALIBER TM Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE® or REVOLVE TM Stabilization Systems.

Source page: https://510kreport.com/device/K102293
Methodology: https://510kreport.com/methodology