510(k) · Cleared
ClearedAnteralign LS coverplate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyber Medical, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jun 10, 2026 as substantially equivalent to K214010 (Medtronic Sofamor Danek USA, 2022) and 1 other predicate after a 90-day review. Its family tree reaches back 30 generations to 1984. 1 of the 839 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 10, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 30 generations to K841189 (1984). 838 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet. 1 of the 839 devices in this family, counting this one, has a Class I recall.
- Root · 30 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 26 generations between
- 3 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 2 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 1 generation backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- This deviceK260810 Anteralign LS coverplateTyber Medical, LLC · 2026
Show all 30 generations
- Root · 30 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 29 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 28 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 27 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 26 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 25 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 24 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 23 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 22 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 21 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 20 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 19 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 18 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 17 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 16 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 15 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 14 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 13 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 12 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 11 generations backK160955 Tritanium® PL CageStryker · 2016
- 10 generations backK162262 Tritanium® PL CageStryker · 2016
- 9 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 8 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 7 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 6 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 5 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 4 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 3 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 2 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 1 generation backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- This deviceK260810 Anteralign LS coverplateTyber Medical, LLC · 2026
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −30 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −29 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −28 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −27 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −26 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −25 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −24 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −23 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −22 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −21 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −20 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −19 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −18 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −17 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −16 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −15 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −14 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −13 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −12 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −11 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −10 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −9 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −8 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −7 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −6 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −5 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −4 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −3 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −2 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −1 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| 0 (this device) | K260810 | Anteralign LS coverplate | Tyber Medical, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 4 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 10 | 0 |
| 1995 | 12 | 0 |
| 1996 | 18 | 0 |
| 1997 | 7 | 0 |
| 1998 | 14 | 0 |
| 1999 | 17 | 0 |
| 2000 | 22 | 0 |
| 2001 | 28 | 0 |
| 2002 | 30 | 0 |
| 2003 | 31 | 0 |
| 2004 | 51 | 0 |
| 2005 | 49 | 0 |
| 2006 | 33 | 0 |
| 2007 | 30 | 0 |
| 2008 | 67 | 1 |
| 2009 | 52 | 0 |
| 2010 | 43 | 0 |
| 2011 | 48 | 0 |
| 2012 | 38 | 0 |
| 2013 | 36 | 0 |
| 2014 | 41 | 0 |
| 2015 | 35 | 0 |
| 2016 | 21 | 0 |
| 2017 | 22 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2023 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface TechnologySummary page 5…3080 Product Code(s) MAX, OVD | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K214010 Anteralign™ Spinal System with Titan nanoLOCK™ Surface MAX Technology K222465 Tyber Medical Anatomical Plating System HRS Devic… | 2022 |
| * | K222465 | Tyber Medical Anatomical Plating SystemSummary page 5…2(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K214010 Anteralign™ Spinal System with Titan nanoLOCK™ Surface MAX Technology K222465 Tyber Medical Anatomical Plating System HRS Device Description Summary 21 CFR 807.92(a)(4) The Anteralign™ LS coverplate System… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 17 companies; a new generation was cleared every 9 months on median.
- 118 of the 838 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K214010.
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. 2026, 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?
When used with Anteralign™ LS Spinal System, the Anteralign™ LS coverplate and cage is only intended to be used according to the indications of Medtronic’s Anteralign™ LS Spinal System. Anteralign™ LS Spinal System Indications for Use The Anteralign™ LS Spinal System is intended to be used in spinal fusion procedures on skeletally mature patients with symptomatic Degenerative Disc Disease (DDD, defined as discogenic pain with degeneration of the disc…
Read the full statement (316 words)
When used with Anteralign™ LS Spinal System, the Anteralign™ LS coverplate and cage is only intended to be used according to the indications of Medtronic’s Anteralign™ LS Spinal System.
Anteralign™ LS Spinal System Indications for Use
The Anteralign™ LS Spinal System is intended to be used in spinal fusion procedures on skeletally mature patients with symptomatic Degenerative Disc Disease (DDD, defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis, at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should have had six months of nonoperative treatment prior to treatment with this device. Additionally, the Anteralign™ LS Spinal System and optional Anteralign™ LS Coverplate can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Anteralign™ LS interbody cage may be used as a stand-alone device or in conjunction with supplemental fixation. The Anteralign LS™ interbody fusion Device e may be inserted via minimally invasive or open anterior or oblique approach at one or two contiguous levels from L2 to S1. These approaches include anterior and oblique. When used as a stand-alone device, the Anteralign™ LS cage must be used with 3 screws with devices that have standard lordosis (<16°). If the physician chooses to use less than 3 screws or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g. posterior fixation) must be used. Additionally, cages with lordosis angles 16° or greater are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation).
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/K260810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260810: Anteralign LS coverplate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260810
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026