# K091301: Life Spine Stand-Alone Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine
- Decided: Dec 15, 2009 after 225 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: 12 generations back to K841189 (1984). 59 ancestors in all.
473 later devices descend from it; 5 cite it directly.
1 of 533 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080411: Plateau Spacer System, Life Spine (2008) Summary page 1.
- K081849: Blackstone Pillar SA Partial Vertebral Body Replacement Device, Blackstone Medical, Inc. (2008) Summary page 1.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 1.
- K081395: Solitaire Peek-Optima Anterior Spinal System, Biomet Spine (2008) Summary page 1.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 1.

## Most influential descendants
- K100802: Aesculap Implant Systems Sibd Spinal System (2010), 461 descendants of its own
- K111122: Aesculap Sibd XP Spinal System (2011), 460 descendants of its own
- K141942: Midline II TI (2014), 459 descendants of its own
- K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti (2015), 368 descendants of its own
- K152475: FORZA PTC Spacer System (2016), 236 descendants of its own

## Indications for use
The Life Spine Stand-Alone Spacer System System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have hzd at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft. The Life Spine Stand-Alone Spacer System System is intended for use with four titanium alloy screws which are provided with the system. If the physician chooses to use fewer than four of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used.

Source page: https://510kreport.com/device/K091301
Methodology: https://510kreport.com/methodology