510(k) · Cleared
ClearedTesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kyocera Medical Technologies, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jul 15, 2026 as substantially equivalent to K212980 (Kyocera Medical Technologies, Inc., 2022) and 2 other predicates after an 82-day review. Its family tree reaches back 27 generations to 1984. 1 of the 644 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 15, 2026
- Review
- 82 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 27 generations to K841189 (1984). 643 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet. 1 of the 644 devices in this family, counting this one, has a Class I recall.
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations between
- 3 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 2 generations backK212980 Tesera-k ALIF SystemKyocera Medical Technologies, Inc. · 2022
- 1 generation backK242771 Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. · 2025
- This deviceK261353 Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL…Kyocera Medical Technologies, Inc. · 2026
Show all 27 generations
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 26 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 25 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 24 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 23 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 21 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 20 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 19 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 17 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 16 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 15 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 14 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 13 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 12 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 11 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 10 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 9 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 8 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 7 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 6 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 5 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 4 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 3 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 2 generations backK212980 Tesera-k ALIF SystemKyocera Medical Technologies, Inc. · 2022
- 1 generation backK242771 Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. · 2025
- This deviceK261353 Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL…Kyocera Medical Technologies, Inc. · 2026
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −26 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −25 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −24 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −23 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −21 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −20 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −19 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −17 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −16 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −15 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −14 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −13 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −12 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −11 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −10 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −9 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −8 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −7 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −6 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −5 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −4 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −3 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −2 | K212980 | Tesera-k ALIF System | Kyocera Medical Technologies, Inc. | 2022 | — |
| −1 | K242771 | Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. | 2025 | — |
| 0 (this device) | K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System… | Kyocera Medical Technologies, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 6 | 0 |
| 1993 | 6 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 10 | 0 |
| 1997 | 6 | 0 |
| 1998 | 10 | 0 |
| 1999 | 11 | 0 |
| 2000 | 18 | 0 |
| 2001 | 22 | 0 |
| 2002 | 24 | 0 |
| 2003 | 27 | 0 |
| 2004 | 45 | 0 |
| 2005 | 38 | 0 |
| 2006 | 24 | 0 |
| 2007 | 25 | 0 |
| 2008 | 56 | 1 |
| 2009 | 45 | 0 |
| 2010 | 31 | 0 |
| 2011 | 41 | 0 |
| 2012 | 24 | 0 |
| 2013 | 29 | 0 |
| 2014 | 35 | 0 |
| 2015 | 23 | 0 |
| 2016 | 14 | 0 |
| 2017 | 11 | 0 |
| 2018 | 9 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 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? (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 |
|---|---|---|---|
| * | K212980 | Tesera-k ALIF SystemSummary page 6…nufacturing and Biocompatibility Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Product Code Predicate Type K212980 Tesera-k ALIF System KMTI OVD, MAX Primary K222554 EL Capta… | 2022 |
| * | K222554 | EL CAPITAN Anterior Lumbar Interbody FusionSummary page 6…Manufacturer Product Code Predicate Type K212980 Tesera-k ALIF System KMTI OVD, MAX Primary K222554 EL Captain ALIF Astura Medical OVD Additional K242771 Teser… | 2023 |
| * | K242771 | Tesera-k PL System and Tesera-k XL SystemSummary page 6…KMTI OVD, MAX Primary K222554 EL Captain ALIF Astura Medical OVD Additional K242771 Tesera- XL System KMTI MAX, OVD Additional The subject device is di… | 2025 |
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 · 5 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 14 companies; a new generation was cleared every 10 months on median.
- 75 of the 643 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K212980.
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?
The Kyocera Medical Technologies, Inc. (KMTI) Lumbar Anchor System is indicated for use with the KMTI Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System and Tesera-K XL System. The KMTI Tesera-K ALIF System is indicated for interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the…
Read the full statement (414 words)
The Kyocera Medical Technologies, Inc. (KMTI) Lumbar Anchor System is indicated for use with the KMTI Tesera-K
Anterior Lumbar Interbody Fusion (ALIF) System and Tesera-K XL System.
The KMTI Tesera-K ALIF System is indicated for interbody fusion procedures in skeletally mature patients with
degenerative disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as
discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients
may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI Tesera-K ALIF System implants
are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-
operative treatment.
Tesera-K SA ALIF cages are intended to be implanted from a direct anterior surgical approach only. Tesera-K SA ALIF
cages are intended to be used with the coverplate and screws provided or with the KMTI Lumbar Anchor System. Tesera-
K SA ALIF assemblies (cage, lumbar anchors, screws and coverplate) featuring one or more lumbar anchors are
considered non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine. The
coverplate assembly is required to be used if any anchors are implanted.
Tesera-K SA ALIF cages are intended to be implanted from a direct anterior surgical approach only. Tesera-K SA ALIF
cages are intended to be used with the coverplate and screws provided. Tesera-K SA ALIF assemblies (cage, screws,
coverplate) that contain cages with lordotic angles less than 20° and use all four screws are standalone and require no
supplemental fixation. Tesera-K SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles
greater than or equal to 20° or if the surgeon chose to use fewer than four screws are considered non standalone and
require supplemental fixation cleared by the FDA for use in the lumbosacral spine.
The Kyocera Medical Technologies, Inc. (KMTI) Tesera-K XL System is indicated for intervertebral body fusion
procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to
S1. KMTI Tesera-K XL System implants are to be used with autogenous or allogenic bone graft. Patients should be
skeletally mature and have at least six weeks of non-operative treatment prior to implantation. The KMTI Tesera-K XL
System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared
by the FDA for use in the lumbar spine.
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/K261353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261353: Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261353
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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