510(k) · Cleared
ClearedLife Spine Stand-Alone Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Dec 15, 2009 as substantially equivalent to K080411 (Life Spine, 2008) and 4 other predicates after a 225-day review. Its family tree reaches back 12 generations to 1984. 1 of the 533 devices in its family, counting itself, has a Class I recall. 473 later devices descend from it.
- Decided
- Dec 15, 2009
- Review
- 225 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K841189 (1984). 59 ancestors in all. 473 later devices descend from it, 5 citing it directly. 1 of the 533 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 2 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 1 generation backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- This deviceK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- Descendant · cites it directly · 461 of its ownK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- Descendant · 2 generations on · 460 of its ownK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- Descendant · 3 generations on · 459 of its ownK141942 Midline II TICentinel Spine, Inc. · 2014
- Descendant · 4 generations on · 368 of its ownK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- Descendant · 5 generations on · 236 of its ownK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 2 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 1 generation backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- This deviceK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
Showing 5 of 473 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 473 · See all- K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010 · cites it directly461descendants
- K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011 · 2 generations on460descendants
- K141942Midline II TICentinel Spine, Inc. · 2014 · 3 generations on459descendants
- K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015 · 4 generations on368descendants
- K152475FORZA PTC Spacer SystemOrthofix, Inc. · 2016 · 5 generations on236descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −2 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −1 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| 0 (this device) | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| +1 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| +2 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| +3 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| +4 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| +5 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 12 | 0 |
| 2017 | 13 | 0 |
| 2018 | 21 | 0 |
| 2019 | 32 | 0 |
| 2020 | 40 | 0 |
| 2021 | 42 | 1 |
| 2022 | 55 | 0 |
| 2023 | 58 | 0 |
| 2024 | 78 | 0 |
| 2025 | 63 | 0 |
| 2026 | 50 | 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 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? (5)
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 |
|---|---|---|---|
| * | K080411 | Plateau Spacer SystemSummary page 1…: MAX — Intervertebral Fusion Device with Bone Graft, Lumbar » 21 CFR 888.3030 — Intervertebral Body Fusion Device Predicate Devices: Life Spine Plateau® §pacer System (K080411) : Blackstone PILLAR ™~ SA PEEK Spacer System (K081849) Synthes SynFix" -LR (K072253) Biomet Solitaire” PEEK-Optima® (K081395) Su… | 2008 |
| * | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement DeviceSummary page 1…umbar » 21 CFR 888.3030 — Intervertebral Body Fusion Device Predicate Devices: Life Spine Plateau® §pacer System (K080411) : Blackstone PILLAR ™~ SA PEEK Spacer System (K081849) Synthes SynFix" -LR (K072253) Biomet Solitaire” PEEK-Optima® (K081395) Surgicraft STALIF™ TT (K073109) Device Description: The… | 2008 |
| * | K072253 | Synfix-LR SpacerSummary page 1…rvertebral Body Fusion Device Predicate Devices: Life Spine Plateau® §pacer System (K080411) : Blackstone PILLAR ™~ SA PEEK Spacer System (K081849) Synthes SynFix" -LR (K072253) Biomet Solitaire” PEEK-Optima® (K081395) Surgicraft STALIF™ TT (K073109) Device Description: The Life Spine Stand-Alone Spacer… | 2007 |
| * | K081395 | Solitaire Peek-Optima Anterior Spinal SystemSummary page 1…Devices: Life Spine Plateau® §pacer System (K080411) : Blackstone PILLAR ™~ SA PEEK Spacer System (K081849) Synthes SynFix" -LR (K072253) Biomet Solitaire” PEEK-Optima® (K081395) Surgicraft STALIF™ TT (K073109) Device Description: The Life Spine Stand-Alone Spacer System implants are intervertebral body… | 2008 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 1…cer System (K080411) : Blackstone PILLAR ™~ SA PEEK Spacer System (K081849) Synthes SynFix" -LR (K072253) Biomet Solitaire” PEEK-Optima® (K081395) Surgicraft STALIF™ TT (K073109) Device Description: The Life Spine Stand-Alone Spacer System implants are intervertebral body fusion devices comprised of a va… | 2008 |
What descends from it? (473)
See all 4735 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 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 8 of the 59 ancestors have a recall of any class.
- Of its descendants, K100802 (Aesculap Implant Systems, Inc., 2010) has gone furthest, with 461 descendants of its own.
- 14 other devices also cite its predicate K080411.
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. 2009, 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 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…
Read the full statement (145 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K091301 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091301: Life Spine Stand-Alone Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091301
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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