510(k) · Cleared
ClearedStalif Midline
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centinel Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 24, 2010 as substantially equivalent to K073109 (Surgicraft, Ltd., 2008) after a 137-day review. Its family tree reaches back 11 generations to 1984. 1 of the 514 devices in its family, counting itself, has a Class I recall. 474 later devices descend from it.
- Decided
- Sep 24, 2010
- Review
- 137 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K841189 (1984). 39 ancestors in all. 474 later devices descend from it, 9 citing it directly. 1 of the 514 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 1 generation backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- This deviceK101301 Stalif MidlineCentinel Spine · 2010
- Descendant · cites it directly · 460 of its ownK133286 Midline (TM)Centinel Spine, Inc. · 2014
- Descendant · cites it directly · 459 of its ownK141942 Midline II TICentinel Spine, Inc. · 2014
- Descendant · cites it directly · 368 of its ownK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- Descendant · 2 generations on · 236 of its ownK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- Descendant · 2 generations on · 220 of its ownK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 1 generation backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- This deviceK101301 Stalif MidlineCentinel Spine · 2010
Showing 5 of 474 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 474 · See all- K133286Midline (TM)Centinel Spine, Inc. · 2014 · cites it directly460descendants
- K141942Midline II TICentinel Spine, Inc. · 2014 · cites it directly459descendants
- K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015 · cites it directly368descendants
- K152475FORZA PTC Spacer SystemOrthofix, Inc. · 2016 · 2 generations on236descendants
- K151214ALIF Interfixated SystemNu Vasive, Incorporated · 2015 · 2 generations on220descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −1 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| 0 (this device) | K101301 | Stalif Midline | Centinel Spine | 2010 | — |
| +1 | K133286 | Midline (TM) | Centinel Spine, Inc. | 2014 | — |
| +1 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| +1 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| +2 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| +2 | K151214 | ALIF Interfixated System | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 12 | 0 |
| 2017 | 13 | 0 |
| 2018 | 21 | 0 |
| 2019 | 32 | 0 |
| 2020 | 42 | 0 |
| 2021 | 42 | 1 |
| 2022 | 54 | 0 |
| 2023 | 58 | 0 |
| 2024 | 78 | 0 |
| 2025 | 62 | 0 |
| 2026 | 51 | 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? (1)
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 |
|---|---|---|---|
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 1…ral body fusion device and unicortical cancellous bone screws intended to be used without supplemental fixation. The purpose of this 510(k) is to modify the STALIETm TT (K073109) to include a modified anti-back out feature and additional sizes.… | 2008 |
What descends from it? (474)
See all 4749 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133286 | Midline (TM) | 2014 | 460 |
| K141942 | Midline II TI | 2014 | 459 |
| K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | 2015 | 368 |
| K173606 | SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu… | 2018 | 59 |
| K130461 | Stalif X | 2013 | 13 |
| K124034 | Mectalif Anterior | 2013 | 11 |
| K212498 | Stable-L Standalone Lumbar Interbody System | 2022 | 7 |
| K181591 | Fixated Asfora BULLET CAGE® (FABC) | 2018 | 0 |
| K141187 | Impix Alif S/a | 2015 | 0 |
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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 6 of the 39 ancestors have a recall of any class.
- Of its descendants, K133286 (Centinel Spine, Inc., 2014) has gone furthest, with 460 descendants of its own.
- 31 other devices also cite its predicate K073109.
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. 2010, 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 STALIF MIDLINE is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of…
Read the full statement (139 words)
The STALIF MIDLINE is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The STALIF MIDLINE is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The STALIF MIDLINE system must be used with bone grafting material (autograft only).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101301: Stalif Midline.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101301
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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