510(k) · Cleared
ClearedScient'x Tribeca VBR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scient'X USA, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 30, 2008 as substantially equivalent to K073202 (Abbott Spine, Inc., 2008) after an 88-day review. Its family tree reaches back 2 generations to 1996. 1 of the 253 devices in its family, counting itself, has a Class I recall. 250 later devices descend from it.
- Decided
- May 30, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P950002 (1996). 250 later devices descend from it, 7 citing it directly. 1 of the 253 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 1 generation backK073202 Ardis SpacerAbbott Spine, Inc. · 2008 · Recalled (Class I)
- This deviceK080588 Scient'x Tribeca VBRScient'X USA, Inc. · 2008
- Descendant · cites it directly · 199 of its ownK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
- Descendant · 2 generations on · 159 of its ownK172888 EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF…Eit Emerging Implant Technologies GmbH · 2017
- Descendant · 3 generations on · 141 of its ownK181644 EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018
- Descendant · 2 generations on · 131 of its ownK183447 EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH · 2019
- Descendant · 3 generations on · 130 of its ownK201605 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF…Eit Emerging Implant Technologies GmbH · 2020
Showing 5 of 250 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacerdirect predicate · 2008
Most influential descendants
Showing 5 of 250 · See all- K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2017 · cites it directly199descendants
- K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2017 · 2 generations on159descendants
- K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018 · 3 generations on141descendants
- K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH · 2019 · 2 generations on131descendants
- K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2020 · 3 generations on130descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −1 | K073202 | Ardis Spacer | Abbott Spine, Inc. | 2008 | Class I |
| 0 (this device) | K080588 | Scient'x Tribeca VBR | Scient'X USA, Inc. | 2008 | — |
| +1 | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT… | Eit Emerging Implant Technologies GmbH | 2017 | 2 |
| +2 | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT… | Eit Emerging Implant Technologies GmbH | 2017 | — |
| +3 | K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | Eit Emerging Implant Technologies GmbH | 2018 | — |
| +2 | K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIF | Eit Emerging Implant Technologies GmbH | 2019 | — |
| +3 | K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT… | Eit Emerging Implant Technologies GmbH | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 8 | 0 |
| 2018 | 8 | 0 |
| 2019 | 10 | 0 |
| 2020 | 19 | 0 |
| 2021 | 15 | 0 |
| 2022 | 26 | 0 |
| 2023 | 35 | 0 |
| 2024 | 39 | 0 |
| 2025 | 44 | 0 |
| 2026 | 36 | 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? (1)
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 |
|---|---|---|---|
| * | K073202 | Ardis SpacerSummary page 2…polymer and is provided non- sterile. Predicate Device(s): The TribecaTM Cage was shown to be substantially equivalent to the Abbott Spine Ardis Spacer (K073202). Performance Standards: Testing performed per ASTM F2077 and F2267 indicates the Tribeca Cage is substantially equivalent to pr… | 2008 |
What descends from it? (250)
See all 2507 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular… | 2017 | 199 |
| K101363 | VU Cpod Intervertebral Bodu Fusion Device | 2010 | 78 |
| K162986 | SPIRA Open Matrix ALIF | 2017 | 11 |
| K172480 | icotec Interbody Cage System | 2018 | 5 |
| K112801 | Ayers Rock Cervical Cage | 2012 | 2 |
| K152355 | Twin Peaks Lumbar Interbody Fusion System | 2015 | 1 |
| K112696 | Twin Peaks Lumbar Cage | 2012 | 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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K170503 (Eit Emerging Implant Technologies GmbH, 2017) has gone furthest, with 199 descendants of its own.
- 10 other devices also cite its predicate K073202.
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. 2008, 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 Scient'x TribecaTM Cage implants are indicated for use with autogenous bone graft as an intervertebral body fusion device at either one or two contiguous levels in the lumbosacral spine, from L2 to SI, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TribecaTM Cage is to be used in…
Read the full statement (119 words)
The Scient'x TribecaTM Cage implants are indicated for use with autogenous bone graft as an intervertebral body fusion device at either one or two contiguous levels in the lumbosacral spine, from L2 to SI, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TribecaTM Cage is to be used in skeletally mature patients who have had six months of non-operative care.
The TribecaTM Cage is implanted using an anterior or posterior approach and is intended to be used single or in pairs with ISOBAR o6.2mm Hemispherical Screws with Offset Clamps and o5.5mm Rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080588: Scient'x Tribeca VBR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080588
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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