510(k) · Cleared
ClearedMidline II TI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centinel Spine, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Nov 7, 2014 as substantially equivalent to K133286 (Centinel Spine, Inc., 2014) and 5 other predicates after a 113-day review. Its family tree reaches back 15 generations to 1984. 1 of the 556 devices in its family, counting itself, has a Class I recall. 459 later devices descend from it.
- Decided
- Nov 7, 2014
- Review
- 113 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 15 generations to K841189 (1984). 96 ancestors in all. 459 later devices descend from it, 4 citing it directly. 1 of the 556 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 2 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 1 generation backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- This deviceK141942 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 · cites it directly · 220 of its ownK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
- Descendant · 2 generations on · 189 of its ownK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- Descendant · 2 generations on · 187 of its ownK152943 NuVasive Foundation-LL SystemNu Vasive, Incorporated · 2015
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 5 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 4 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 3 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 2 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 1 generation backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- This deviceK141942 Midline II TICentinel Spine, Inc. · 2014
Showing 5 of 459 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 459 · See all- 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 · cites it directly220descendants
- K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA · 2016 · 2 generations on189descendants
- K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated · 2015 · 2 generations on187descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −5 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −4 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −3 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −2 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −1 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| 0 (this device) | 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 | — |
| +1 | K151214 | ALIF Interfixated System | Nu Vasive, Incorporated | 2015 | — |
| +2 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… | Ldr Spine USA | 2016 | 1 |
| +2 | K152943 | NuVasive Foundation-LL 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 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 12 | 0 |
| 2005 | 10 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 4 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 21 | 0 |
| 2019 | 31 | 0 |
| 2020 | 39 | 0 |
| 2021 | 42 | 1 |
| 2022 | 53 | 0 |
| 2023 | 57 | 0 |
| 2024 | 78 | 0 |
| 2025 | 61 | 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? (6)
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 |
|---|---|---|---|
| * | K133286 | Midline (TM)Summary page 4…cations: 21 CFR §888.3080, Intervertebral body fusion device Class: II Product Codes: OVD Primary Predicate: K133286 (MIDLINE™) Additional Predicates: STALIF MIDLINETM (K101301), Aesculap SIBD XP Spinal System… | 2014 |
| * | K101301 | Stalif MidlineSummary page 4…evice Class: II Product Codes: OVD Primary Predicate: K133286 (MIDLINE™) Additional Predicates: STALIF MIDLINETM (K101301), Aesculap SIBD XP Spinal System (K111122), SpineSmith Cynch Spinal System (K102090),… | 2010 |
| * | K111122 | Aesculap Sibd XP Spinal SystemSummary page 4…D Primary Predicate: K133286 (MIDLINE™) Additional Predicates: STALIF MIDLINETM (K101301), Aesculap SIBD XP Spinal System (K111122), SpineSmith Cynch Spinal System (K102090), NuVasive Brigade Hyperlodotic System (K123045), Theken S… | 2011 |
| * | K102090 | Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemSummary page 4…IDLINE™) Additional Predicates: STALIF MIDLINETM (K101301), Aesculap SIBD XP Spinal System (K111122), SpineSmith Cynch Spinal System (K102090), NuVasive Brigade Hyperlodotic System (K123045), Theken Spine VuaPOD (… | 2010 |
| * | K123045 | Brigade Standalone SystemSummary page 4…IBD XP Spinal System (K111122), SpineSmith Cynch Spinal System (K102090), NuVasive Brigade Hyperlodotic System (K123045), Theken Spine VuaPOD (K101310) Reference Device: K133200 (STALIF C® Ti) Indications Fo… | 2013 |
| * | K101310 | VU Apod Intervertebral Body Fusion DeviceSummary page 4…SpineSmith Cynch Spinal System (K102090), NuVasive Brigade Hyperlodotic System (K123045), Theken Spine VuaPOD (K101310) Reference Device: K133200 (STALIF C® Ti) Indications For Use: The MIDLINE II™ / MIDLINE II-Ti™ is indicated for use… | 2010 |
| † | K133200 | Stalif C (R) | 2014 |
What descends from it? (459)
See all 4594 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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 13 companies; a new generation was cleared every 1.0 years on median.
- 16 of the 96 ancestors have a recall of any class.
- Of its descendants, K150643 (Centinel Spine, Inc., 2015) has gone furthest, with 368 descendants of its own.
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. 2014, 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 MIDLINE II™ / MIDLINE II -Ti™ 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…
Read the full statement (151 words)
The MIDLINE II™ / MIDLINE II -Ti™ 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 MIDLINE II™ / MIDLINE II -Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The MIDLINE II™ / MIDLINE II -Ti™ system must be used with bone grafting material (autograft only).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141942: Midline II TI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141942
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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