510(k) · Cleared
ClearedScala® TL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineart SA · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Aug 20, 2026 as substantially equivalent to K163364 (K2m, 2017) and 4 other predicates after a 142-day review. Its family tree reaches back 22 generations to 1984. 1 of the 357 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 20, 2026
- Review
- 142 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 22 generations to K841189 (1984). 356 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 357 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 2 generations backK170318 NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC · 2017
- 1 generation backK192115 SABLE Expandable SpacerGlobus Medical, Inc. · 2020
- This deviceK261049 Scala® TLSpineart SA · 2026
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 4 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 3 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 2 generations backK170318 NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC · 2017
- 1 generation backK192115 SABLE Expandable SpacerGlobus Medical, Inc. · 2020
- This deviceK261049 Scala® TLSpineart SA · 2026
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −4 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −3 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −2 | K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | Ht Medical, LLC | 2017 | — |
| −1 | K192115 | SABLE Expandable Spacer | Globus Medical, Inc. | 2020 | — |
| 0 (this device) | K261049 | Scala® TL | Spineart SA | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 17 | 0 |
| 2004 | 28 | 0 |
| 2005 | 19 | 0 |
| 2006 | 13 | 0 |
| 2007 | 18 | 0 |
| 2008 | 44 | 1 |
| 2009 | 29 | 0 |
| 2010 | 18 | 0 |
| 2011 | 26 | 0 |
| 2012 | 21 | 0 |
| 2013 | 24 | 0 |
| 2014 | 20 | 0 |
| 2015 | 10 | 0 |
| 2016 | 10 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K163364 | MOJAVE Expandable Interbody SystemSummary page 5…888.3080 Product Code(s) MAX | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K163364 MOJAVE Expandable Interbody System MAX K171633 NuVasive TLX Interbody System MAX K192115 SABLE Expandable Spacer MAX K153621, K18… | 2017 |
| * | K171633 | NuVasive TLX Interbody SystemSummary page 5…ed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K163364 MOJAVE Expandable Interbody System MAX K171633 NuVasive TLX Interbody System MAX K192115 SABLE Expandable Spacer MAX K153621, K181203 | | Juliet Ti MAX Device Description Summa… | 2017 |
| * | K192115 | SABLE Expandable SpacerSummary page 5…redicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K163364 MOJAVE Expandable Interbody System MAX K171633 NuVasive TLX Interbody System MAX K192115 SABLE Expandable Spacer MAX K153621, K181203 | | Juliet Ti MAX Device Description Summary 21 CFR 807.92(a)(4) The SCALA® TL Post… | 2020 |
| * | K153621 | Juliet® TiSummary page 5…mary Predicate is listed first) Product Code K163364 MOJAVE Expandable Interbody System MAX K171633 NuVasive TLX Interbody System MAX K192115 SABLE Expandable Spacer MAX K153621, K181203 | | Juliet Ti MAX Device Description Summary 21 CFR 807.92(a)(4) The SCALA® TL Posterior Expandable Cage System has bee… | 2016 |
| * | K181203 | Juliet TiSummary page 5…icate is listed first) Product Code K163364 MOJAVE Expandable Interbody System MAX K171633 NuVasive TLX Interbody System MAX K192115 SABLE Expandable Spacer MAX K153621, K181203 | | Juliet Ti MAX Device Description Summary 21 CFR 807.92(a)(4) The SCALA® TL Posterior Expandable Cage System has been designe… | 2018 |
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 · 4 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 16 companies; a new generation was cleared every 11 months on median.
- 38 of the 356 ancestors have a recall of any class; 1 has a Class I recall.
- 6 other devices also cite its predicate K163364.
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. 2026, 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 SCALA® TL Posterior Expandable Cage System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L1-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. It is…
Read the full statement (158 words)
The SCALA® TL Posterior Expandable Cage System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L1-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. It is used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental spinal fixation system that is cleared for use in the lumbosacral spine.
Additionally, the SCALA® TL Posterior Expandable Cage System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
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/K261049 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261049: Scala® TL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261049
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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