510(k) · Cleared
ClearedARx Spinal 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 22, 2021 as substantially equivalent to K123373 (Life Spine, 2013) and 2 other predicates after a 56-day review. Its family tree reaches back 22 generations to 2004. 1 of the 594 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Apr 22, 2021
- Review
- 56 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K040583 (2004). 592 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 1 of the 594 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations between
- 3 generations backK182974 NuVasive Reline SystemNu Vasive, Incorporated · 2019
- 2 generations backK191575 ARx Spinal SystemLife Spine, Inc. · 2019
- 1 generation backK200070 ARx Spinal SystemLife Spine, Inc. · 2020
- This deviceK210549 ARx Spinal SystemLife Spine, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK220025 ARx® Spinal SystemLife Spine, Inc. · 2022
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 backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 7 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 6 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 5 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- 4 generations backK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017
- 3 generations backK182974 NuVasive Reline SystemNu Vasive, Incorporated · 2019
- 2 generations backK191575 ARx Spinal SystemLife Spine, Inc. · 2019
- 1 generation backK200070 ARx Spinal SystemLife Spine, Inc. · 2020
- This deviceK210549 ARx Spinal SystemLife Spine, Inc. · 2021
Class I recalls in this family
- K100952 Modification to Synthes Matrix System5 generations back · 2010
Most influential descendants
Showing 1 of 1 · See all- K220025ARx® Spinal SystemLife Spine, Inc. · 2022 · cites it directly0descendants
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 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −7 | K141604 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −6 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| −5 | K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| −4 | K170126 | NuVasive® Reline® 4.5-5.0 System | Nu Vasive, Incorporated | 2017 | — |
| −3 | K182974 | NuVasive Reline System | Nu Vasive, Incorporated | 2019 | — |
| −2 | K191575 | ARx Spinal System | Life Spine, Inc. | 2019 | — |
| −1 | K200070 | ARx Spinal System | Life Spine, Inc. | 2020 | — |
| 0 (this device) | K210549 | ARx Spinal System | Life Spine, Inc. | 2021 | — |
| +1 | K220025 | ARx® Spinal System | Life Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 16 | 0 |
| 1996 | 11 | 0 |
| 1997 | 14 | 0 |
| 1998 | 21 | 0 |
| 1999 | 19 | 0 |
| 2000 | 30 | 0 |
| 2001 | 37 | 0 |
| 2002 | 28 | 0 |
| 2003 | 32 | 0 |
| 2004 | 55 | 0 |
| 2005 | 44 | 0 |
| 2006 | 39 | 0 |
| 2007 | 32 | 0 |
| 2008 | 32 | 0 |
| 2009 | 28 | 0 |
| 2010 | 26 | 1 |
| 2011 | 22 | 0 |
| 2012 | 11 | 0 |
| 2013 | 15 | 0 |
| 2014 | 12 | 0 |
| 2015 | 8 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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 |
|---|---|---|---|
| * | K123373 | Nautilus Spinal SystemSummary page 4…Name: Thoracolumbosacral Pedicle Screw System Classification: NKB CFR 888.3070, Class II Primary Predicate: Life Spine Nautilus (K123373) Additional Predicate: Stryker Xia 3 Spinal System (K142381) Life Spine AR CoCr Pedicle Scre… | 2013 |
| * | K142381 | Xia 3 Spinal SystemSummary page 4…ification: NKB CFR 888.3070, Class II Primary Predicate: Life Spine Nautilus (K123373) Additional Predicate: Stryker Xia 3 Spinal System (K142381) Life Spine AR CoCr Pedicle Screw System (K200070) Device Description: The ARX Spinal System con… | 2014 |
| * | K200070 | ARx Spinal SystemSummary page 4…Life Spine Nautilus (K123373) Additional Predicate: Stryker Xia 3 Spinal System (K142381) Life Spine AR CoCr Pedicle Screw System (K200070) Device Description: The ARX Spinal System consists of screws and longitudinal rods intended to provide temporary stabilizati… | 2020 |
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 |
|---|---|---|---|
| K220025 | ARx® Spinal System | 2022 | 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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 7 months on median.
- 74 of the 592 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K220025 (Life Spine, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K123373.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Spinal System, is intended for posterior pedicle screw fixation of the non-cervical posterior spine (Tl to S2/ilium) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be…
Read the full statement (185 words)
The ARx Spinal System, is intended for posterior pedicle screw fixation of the non-cervical posterior spine (Tl to S2/ilium) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When used as a posterior spine thoracic/lumbar system, the ARx Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures and spinal deformity (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (6) spinal stenosis, (7) spondylolisthesis.
In order to achieve additional levels of fixation in skeletally mature patients, the ARx Spinal System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210549: ARx Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210549
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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