# K080537: L-Varlock

- Pathway: 510(k) (Traditional)
- Applicant: Kiscomedica S.A.
- Decided: Jun 30, 2008 after 124 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
958 later devices descend from it; 13 cite it directly.
1 of 959 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K102293: Caliber Spacer (2011), 869 descendants of its own
- K111512: Bonebac T-Plif Intervertebral Body Fusion Device System (2011), 762 descendants of its own
- K120368: Capstone Control Spinal System (2012), 761 descendants of its own
- K121760: Capstone Spinal System (2012), 723 descendants of its own
- K113465: Acculif TL Cage (2011), 718 descendants of its own

## Recalls of this device
- Jan 11, 2017 · Class II · Z-1461-2017: Firm received a complaint of the tip holder breaking during use.

## Indications for use
The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K080537
Methodology: https://510kreport.com/methodology