510(k) · Cleared
ClearedTriALTIS™ Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 17, 2025 as substantially equivalent to K231479 (Medos International SARL, 2023) and 3 other predicates after a 98-day review. Its family tree reaches back 22 generations to 2004.
- Decided
- Jan 17, 2025
- Review
- 98 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 22 generations to K040583 (2004). 238 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations between
- 3 generations backK231479 TriALTIS Spine SystemMedos International SARL · 2023
- 2 generations backK233684 TriALTIS™ Spine SystemMedos International SARL · 2023
- 1 generation backK242042 TriALTIS™ Spine SystemMedos International SARL · 2024
- This deviceK243249 TriALTIS™ Spine SystemMedos International SARL · 2025
Show all 22 generations
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 21 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 20 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 19 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 18 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 17 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 15 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 14 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 13 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 12 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 11 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 10 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 9 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 8 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 7 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- 6 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- 5 generations backK200245 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl · 2020
- 4 generations backK220374 EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL · 2022
- 3 generations backK231479 TriALTIS Spine SystemMedos International SARL · 2023
- 2 generations backK233684 TriALTIS™ Spine SystemMedos International SARL · 2023
- 1 generation backK242042 TriALTIS™ Spine SystemMedos International SARL · 2024
- This deviceK243249 TriALTIS™ Spine SystemMedos International SARL · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −21 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −20 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −19 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −18 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −17 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −15 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −14 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −13 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −12 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −11 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −10 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −9 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −8 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −7 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| −6 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| −5 | K200245 | EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System | Medos International Sàrl | 2020 | — |
| −4 | K220374 | EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) | Medos International SARL | 2022 | — |
| −3 | K231479 | TriALTIS Spine System | Medos International SARL | 2023 | — |
| −2 | K233684 | TriALTIS™ Spine System | Medos International SARL | 2023 | — |
| −1 | K242042 | TriALTIS™ Spine System | Medos International SARL | 2024 | — |
| 0 (this device) | K243249 | TriALTIS™ Spine System | Medos International SARL | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 10 | 0 |
| 1999 | 10 | 0 |
| 2000 | 16 | 0 |
| 2001 | 21 | 0 |
| 2002 | 11 | 0 |
| 2003 | 14 | 0 |
| 2004 | 24 | 0 |
| 2005 | 23 | 0 |
| 2006 | 16 | 0 |
| 2007 | 9 | 0 |
| 2008 | 8 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 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.
Planning a device in NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K231479 | TriALTIS Spine SystemSummary page 5…3070 Product Code(s) NKB, PML | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K231479 TriALTIS™ Spine System NKB K233684 TriALTIS™ Spine System NKB K242042 TriALTIS™ Spine System NKB K073126 EXPEDIUM Spine System NK… | 2023 |
| * | K233684 | TriALTIS™ Spine SystemSummary page 5…gally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K231479 TriALTIS™ Spine System NKB K233684 TriALTIS™ Spine System NKB K242042 TriALTIS™ Spine System NKB K073126 EXPEDIUM Spine System NKB Device Description Summary 21 CFR… | 2023 |
| * | K242042 | TriALTIS™ Spine SystemSummary page 5…CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K231479 TriALTIS™ Spine System NKB K233684 TriALTIS™ Spine System NKB K242042 TriALTIS™ Spine System NKB K073126 EXPEDIUM Spine System NKB Device Description Summary 21 CFR 807.92(a)(4) The TriALTIS™ Spine… | 2024 |
| * | K073126 | Expedium Spine SystemSummary page 5…cate Trade Name (Primary Predicate is listed first) Product Code K231479 TriALTIS™ Spine System NKB K233684 TriALTIS™ Spine System NKB K242042 TriALTIS™ Spine System NKB K073126 EXPEDIUM Spine System NKB Device Description Summary 21 CFR 807.92(a)(4) The TriALTIS™ Spine System is a posterior spinal fixati… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 5 months on median.
- 29 of the 238 ancestors have a recall of any class.
- 4 other devices also cite its predicate K231479.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The TriALTIS™ Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation for the following indications: degenerative disc disease…
Read the full statement (297 words)
The TriALTIS™ Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic,
lumbar and sacral spine.
The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and
nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin
with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or
dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudarthrosis; and failed
previous fusions in skeletally mature patients.
When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the
TriALTIS™ Spine System is indicated as an adjunct to fusion to treat spinal deformities (i.e., scoliosis, kyphosis, or
lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the
TriALTIS™ Spine System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture
caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTIS™ Spine System is intended
to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosity
Spinal Cement, the TriALTIS™ Spine System is intended to stabilize the spinal column even in the absence of fusion for
a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life
expectancy is of insufficient duration to permit achievement of fusion. The TriALTIS™ fenestrated screws augmented
with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the
spine is not severely compromised.
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/K243249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243249: TriALTIS™ Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243249
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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