510(k) · Cleared
ClearedARx® SAI Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 16, 2026 as substantially equivalent to K241464 (Life Spine, Inc., 2024) and 2 other predicates after a 107-day review. Its family tree reaches back 33 generations to 1984. 2 of the 1,242 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 16, 2026
- Review
- 107 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 33 generations to K841189 (1984). 1,241 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 2 of the 1,242 devices in this family, counting this one, have a Class I recall.
- Root · 33 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 29 generations between
- 3 generations backK223494 CD Horizon Spinal SystemMedtronic · 2023
- 2 generations backK233508 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024
- 1 generation backK241464 ARx® SAI Implant SystemLife Spine, Inc. · 2024
- This deviceK254274 ARx® SAI Implant SystemLife Spine, Inc. · 2026
Show all 33 generations
- Root · 33 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 32 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 31 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 30 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 29 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 28 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 27 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 26 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 25 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 24 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 23 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 22 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 21 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 20 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 19 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 18 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 17 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 16 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 15 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 14 generations backK160955 Tritanium® PL CageStryker · 2016
- 13 generations backK162262 Tritanium® PL CageStryker · 2016
- 12 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 11 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 10 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 9 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 8 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 7 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 6 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 5 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 4 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 3 generations backK223494 CD Horizon Spinal SystemMedtronic · 2023
- 2 generations backK233508 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024
- 1 generation backK241464 ARx® SAI Implant SystemLife Spine, Inc. · 2024
- This deviceK254274 ARx® SAI Implant SystemLife Spine, Inc. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −33 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −32 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −31 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −30 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −29 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −28 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −27 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −26 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −25 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −24 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −23 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −22 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −21 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −20 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −19 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −18 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −17 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −16 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −15 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −14 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −13 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −12 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −11 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −10 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −9 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −8 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −7 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −6 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −5 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −4 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| −3 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
| −2 | K233508 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2024 | — |
| −1 | K241464 | ARx® SAI Implant System | Life Spine, Inc. | 2024 | — |
| 0 (this device) | K254274 | ARx® SAI Implant System | Life Spine, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 7 | 0 |
| 1993 | 5 | 0 |
| 1994 | 9 | 0 |
| 1995 | 18 | 0 |
| 1996 | 17 | 0 |
| 1997 | 15 | 0 |
| 1998 | 25 | 0 |
| 1999 | 21 | 0 |
| 2000 | 35 | 0 |
| 2001 | 47 | 0 |
| 2002 | 47 | 0 |
| 2003 | 50 | 0 |
| 2004 | 76 | 0 |
| 2005 | 71 | 0 |
| 2006 | 57 | 0 |
| 2007 | 53 | 0 |
| 2008 | 91 | 1 |
| 2009 | 73 | 0 |
| 2010 | 61 | 1 |
| 2011 | 76 | 0 |
| 2012 | 51 | 0 |
| 2013 | 55 | 0 |
| 2014 | 53 | 0 |
| 2015 | 58 | 0 |
| 2016 | 35 | 0 |
| 2017 | 33 | 0 |
| 2018 | 15 | 0 |
| 2019 | 11 | 0 |
| 2020 | 14 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 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.
2 devices in this family have 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 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? (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 |
|---|---|---|---|
| * | K241464 | ARx® SAI Implant SystemSummary page 5…ification: OUR CFR 888.3040, Class II NKB, CFR 888.3070, Class II Primary Predicate: Life Spine ARx SAI Implant System (K241464) Additional Predicate: Life Spine Sacroiliac Joint Fixation Screw System (K141246) Life Spine… | 2024 |
| * | K141246 | Life Spine Sacroiliac Joint Fixation SystemSummary page 5….3070, Class II Primary Predicate: Life Spine ARx SAI Implant System (K241464) Additional Predicate: Life Spine Sacroiliac Joint Fixation Screw System (K141246) Life Spine ARx SAI Implant System (K241464) SI-Bone, Inc. iFuse Bedrock… | 2015 |
| * | K233508 | iFuse Bedrock Granite® Implant SystemSummary page 5…System (K141246) Life Spine ARx SAI Implant System (K241464) SI-Bone, Inc. iFuse Bedrock Granite Implant System (K233508) Device Reference: Life Spine Arx MIS Spinal Screw System (K233455) Device Description: The ARx® SAI Implant System… | 2024 |
| † | K233455 | ARx MIS Spinal Screw System | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 42 years and passes through 19 companies; a new generation was cleared every 9 months on median.
- 143 of the 1,241 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 ARx® SAI Implant System is intended for sacroiliac joint fusion for the following conditions: Sacroiliac joint dysfunction and degenerative sacroiliitis include conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or…
Read the full statement (196 words)
The ARx® SAI Implant System is intended for sacroiliac joint fusion for the following conditions:
Sacroiliac joint dysfunction and degenerative sacroiliitis include conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
When connected to compatible pedicle screws with 5.5- or 6.0-mm posterior rods made from either titanium alloys or cobalt chrome, the ARx® SAI Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
Spondylolisthesis
Trauma (i.e., fracture or dislocation)
Spinal Stenosis
Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis)
Spinal tumor
Pseudarthrosis
Failed previous fusion
Please refer to the Instructions for Use/Package Insert for additional information on compatible systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254274: ARx® SAI Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254274
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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