510(k) · Cleared
ClearedSolitarie Peek Anterior Spinal System-to BE Called Colitaire 35
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine & Bone Healing Technologies · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Mar 19, 2012 as substantially equivalent to K081395 (Biomet Spine, 2008) and 2 other predicates after a 24-day review. Its family tree reaches back 7 generations to 2001. 1 later device descends from it.
- Decided
- Mar 19, 2012
- Review
- 24 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K010530 (2001). 15 ancestors in all, the oldest P950002 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 6 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 5 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 4 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 3 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 2 generations backK081636 Peek-Optima Alif SpacerBiomet Spine · 2008
- 1 generation backK082406 Expandable Peek-Optima ImplantEbi, L.P. · 2009
- This deviceK120557 Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies · 2012
- Descendant · cites it directly · 0 of its ownK130641 Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −6 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −5 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −4 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −3 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −2 | K081636 | Peek-Optima Alif Spacer | Biomet Spine | 2008 | — |
| −1 | K082406 | Expandable Peek-Optima Implant | Ebi, L.P. | 2009 | — |
| 0 (this device) | K120557 | Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35 | Biomet Spine & Bone Healing Technologies | 2012 | — |
| +1 | K130641 | Logic Stand-Alone Intervertebral Body Fusion Device | Binder Biomedical, Inc. | 2013 | — |
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 |
| 2008 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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.
Planning a device in OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K081395 | Solitaire Peek-Optima Anterior Spinal SystemSummary page 1…ponents are the same as, or similar to, the predicate devices. Examples of predicate devices include: " Solitaire PEE K-Optima Anterior Spinal System (Biomet Spine - K08 1395) * Independence Spacer (Globus Medical - K082252) * Expandable PEEK Spacer (Biomet Spine - K082406)… | 2008 |
| * | K082252 | Independence SpacerSummary page 1…devices. Examples of predicate devices include: " Solitaire PEE K-Optima Anterior Spinal System (Biomet Spine - K08 1395) * Independence Spacer (Globus Medical - K082252) * Expandable PEEK Spacer (Biomet Spine - K082406)… | 2008 |
| * | K082406 | Expandable Peek-Optima ImplantSummary page 1…Solitaire PEE K-Optima Anterior Spinal System (Biomet Spine - K08 1395) * Independence Spacer (Globus Medical - K082252) * Expandable PEEK Spacer (Biomet Spine - K082406) Page 5-2 Performa… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130641 | Logic Stand-Alone Intervertebral Body Fusion Device | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 7 companies; a new generation was cleared every 5 months on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K130641 (Binder Biomedical, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K081395.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The Solitaire® PEEK Anterior Spinal System is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120557: Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120557
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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