510(k) · Cleared
ClearedTesera-k PL System and Tesera-k XL System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kyocera Medical Technologies, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 20, 2025 as substantially equivalent to K172816 (Choicespine, LP, 2018) and 4 other predicates after a 188-day review. Its family tree reaches back 26 generations to 1984. 1 of the 611 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Mar 20, 2025
- Review
- 188 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 26 generations to K841189 (1984). 609 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 611 devices in this family, counting this one, has a Class I recall.
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations between
- 3 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 1 generation backK212980 Tesera-k ALIF SystemKyocera Medical Technologies, Inc. · 2022
- This deviceK242771 Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK261353 Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL…Kyocera Medical Technologies, Inc. · 2026
Show all 26 generations
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 24 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 23 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 20 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 19 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 16 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 15 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 14 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 13 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 12 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 11 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 10 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 9 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 8 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 6 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 5 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 4 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 3 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 1 generation backK212980 Tesera-k ALIF SystemKyocera Medical Technologies, Inc. · 2022
- This deviceK242771 Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. · 2025
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −25 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −24 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −23 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −20 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −19 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −16 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −15 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −14 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −13 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −12 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −11 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −10 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −9 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −8 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −6 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −4 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −3 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −2 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −1 | K212980 | Tesera-k ALIF System | Kyocera Medical Technologies, Inc. | 2022 | — |
| 0 (this device) | K242771 | Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. | 2025 | — |
| +1 | 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 | 21 | 0 |
| 2002 | 23 | 0 |
| 2003 | 27 | 0 |
| 2004 | 45 | 0 |
| 2005 | 38 | 0 |
| 2006 | 24 | 0 |
| 2007 | 24 | 0 |
| 2008 | 54 | 1 |
| 2009 | 42 | 0 |
| 2010 | 31 | 0 |
| 2011 | 38 | 0 |
| 2012 | 22 | 0 |
| 2013 | 26 | 0 |
| 2014 | 34 | 0 |
| 2015 | 18 | 0 |
| 2016 | 12 | 0 |
| 2017 | 8 | 0 |
| 2018 | 7 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K172816 | TiGer Shark™ SystemSummary page 6…urer Product Code Predicate Number Type K172816 TiGer Shark System Choice Spine, LP MAX Primary K133614 Aleutian IBF… | 2018 |
| * | K133614 | Aleutian Ibf SystemSummary page 6…Type K172816 TiGer Shark System Choice Spine, LP MAX Primary K133614 Aleutian IBF System K2M, Inc. MAX, MQP, ODP Additional K172341 NuVasive… | 2014 |
| * | K172341 | NuVasive® Modulus TLIF Interbody SystemSummary page 6…, LP MAX Primary K133614 Aleutian IBF System K2M, Inc. MAX, MQP, ODP Additional K172341 NuVasive Modulus TLIF Interbody System NuVasive, Inc. MAX, PHM Additional K181655 Renovis S… | 2017 |
| * | K181655 | Renovis S180 Lateral Lumbar Interbody Fusion SystemSummary page 6…MAX, MQP, ODP Additional K172341 NuVasive Modulus TLIF Interbody System NuVasive, Inc. MAX, PHM Additional K181655 Renovis S180 Lateral Lumbar Interbody System Renovis Surgical Technologies MAX Additional K212980 Tesera-k… | 2018 |
| * | K212980 | Tesera-k ALIF SystemSummary page 6…MAX, PHM Additional K181655 Renovis S180 Lateral Lumbar Interbody System Renovis Surgical Technologies MAX Additional K212980 Tesera-k ALIF System Kyocera Medical Technologies, Inc. MAX, OVD Additional PERFORMANCE DATA… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar… | 2026 | 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.
- 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 41 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 73 of the 609 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K261353 (Kyocera Medical Technologies, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K172816.
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. 2025, 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 Kyocera Medical Technologies, Inc. (KMTI) Tesera-k PL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) at one or two contiguous levels from L2 to S1. KMTI Teresa-K PL System implants are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of…
Read the full statement (215 words)
The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k PL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) at one or two contiguous levels from L2 to S1. KMTI Teresa-K PL System implants are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k PL 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.
The Kyocera Medica l Technologies, Inc. (KMTI) Tesera-k XL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) at one or two contiguous levels from L2 to S1. KMTI Tesera-k XL System implants arare to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months 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 a dditiona l supplemental fixation that have been cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242771 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242771: Tesera-k PL System and Tesera-k XL System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242771
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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