# K081636: Peek-Optima Alif Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine
- Decided: Aug 7, 2008 after 57 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: 5 generations back to K010530 (2001). 10 ancestors in all.
542 later devices descend from it; 4 cite it directly.
1 of 553 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX, Stryker Spine (2008) Summary page 1.
- K080758: Avs PL Peek Spacers, Models 48351 and 48353, Stryker Corp. (2008) Summary page 1.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 1.
- K040928: Expandable Peek VBR Implant, Interpore Cross Intl. (2004) Summary page 1.

## Most influential descendants
- K082406: Expandable Peek-Optima Implant (2009), 527 descendants of its own
- K092336: C-Thru Spinal System (2009), 492 descendants of its own
- K100214: Cornerstone PSR Cervical Interbody Fusion Device (2010), 389 descendants of its own
- K111264: Cornerstone (R) PSR Cervical Fusion System (2011), 331 descendants of its own
- K112444: Anatomic Peek Cervical Fusion System (2011), 324 descendants of its own

## Indications for use
The PEEK-OPTIMA ® ALIF Spacer is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to SI in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The PEEK-OPTIMA® ALIF Spacer is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K081636
Methodology: https://510kreport.com/methodology