510(k) · Cleared
ClearedPeek-Optima Alif Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Aug 7, 2008 as substantially equivalent to K073470 (Stryker Spine, 2008) and 3 other predicates after a 57-day review. Its family tree reaches back 5 generations to 2001. 1 of the 553 devices in its family, counting itself, has a Class I recall. 542 later devices descend from it.
- Decided
- Aug 7, 2008
- Review
- 57 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K010530 (2001). 10 ancestors in all, the oldest P950002 (1996). 542 later devices descend from it, 4 citing it directly. 1 of the 553 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 4 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 3 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 2 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 1 generation backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- This deviceK081636 Peek-Optima Alif SpacerBiomet Spine · 2008
- Descendant · cites it directly · 527 of its ownK082406 Expandable Peek-Optima ImplantEbi, L.P. · 2009
- Descendant · 2 generations on · 492 of its ownK092336 C-Thru Spinal SystemEbi, L.P. · 2009
- Descendant · 3 generations on · 389 of its ownK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- Descendant · 4 generations on · 331 of its ownK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- Descendant · 4 generations on · 324 of its ownK112444 Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011
Showing 5 of 542 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 542 · See all- K082406Expandable Peek-Optima ImplantEbi, L.P. · 2009 · cites it directly527descendants
- K092336C-Thru Spinal SystemEbi, L.P. · 2009 · 2 generations on492descendants
- K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010 · 3 generations on389descendants
- K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011 · 4 generations on331descendants
- K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011 · 4 generations on324descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −4 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −3 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −2 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −1 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| 0 (this device) | K081636 | Peek-Optima Alif Spacer | Biomet Spine | 2008 | — |
| +1 | K082406 | Expandable Peek-Optima Implant | Ebi, L.P. | 2009 | — |
| +2 | K092336 | C-Thru Spinal System | Ebi, L.P. | 2009 | — |
| +3 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| +4 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| +4 | K112444 | Anatomic Peek Cervical Fusion System | Medtronic Sofamor Danck USA, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 9 | 0 |
| 2014 | 10 | 0 |
| 2015 | 9 | 0 |
| 2016 | 16 | 0 |
| 2017 | 32 | 0 |
| 2018 | 25 | 0 |
| 2019 | 41 | 0 |
| 2020 | 37 | 0 |
| 2021 | 52 | 1 |
| 2022 | 49 | 0 |
| 2023 | 58 | 0 |
| 2024 | 62 | 0 |
| 2025 | 63 | 0 |
| 2026 | 61 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXXSummary page 1…ational principles. Examples of other predicate intervertebral body fusion devices distributed for the similar indications include the Stryker Spine AVS PL-PEEK Spacers (K073470 and K080758) and Synthes' SynFiXTM -LR (K072253) while the Interpore Cross Expandable PEEK VBR Implant (K040928) has similar desi… | 2008 |
| * | K080758 | Avs PL Peek Spacers, Models 48351 and 48353Summary page 1…ciples. Examples of other predicate intervertebral body fusion devices distributed for the similar indications include the Stryker Spine AVS PL-PEEK Spacers (K073470 and K080758) and Synthes' SynFiXTM -LR (K072253) while the Interpore Cross Expandable PEEK VBR Implant (K040928) has similar design features.… | 2008 |
| * | K072253 | Synfix-LR SpacerSummary page 1…intervertebral body fusion devices distributed for the similar indications include the Stryker Spine AVS PL-PEEK Spacers (K073470 and K080758) and Synthes' SynFiXTM -LR (K072253) while the Interpore Cross Expandable PEEK VBR Implant (K040928) has similar design features. Based upon the mechanical testing,… | 2007 |
| * | K040928 | Expandable Peek VBR ImplantSummary page 1…ndications include the Stryker Spine AVS PL-PEEK Spacers (K073470 and K080758) and Synthes' SynFiXTM -LR (K072253) while the Interpore Cross Expandable PEEK VBR Implant (K040928) has similar design features. Based upon the mechanical testing, the PEEK ALIF is substantially equivalent for its intended use t… | 2004 |
What descends from it? (542)
See all 5424 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K082406 (Ebi, L.P., 2009) has gone furthest, with 527 descendants of its own.
- 17 other devices also cite its predicate K073470.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081636 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081636: Peek-Optima Alif Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081636
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026