510(k) Report

510(k) · Cleared

Cleared

ARx® Spinal System

K220025510(k) TraditionalCleared Mar 31, 202285-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Life Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Mar 31, 2022 as substantially equivalent to K141222 (Life Spine, Inc., 2015) and 10 other predicates after an 85-day review. Its family tree reaches back 23 generations to 2004. 1 of the 665 devices in its family, counting itself, has a Class I recall.

Decided
Mar 31, 2022
Review
85 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
11

Its longest line of descent runs back 23 generations to K040583 (2004). 664 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 665 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2021: 1 other ancestor2019: 1 other ancestor2017: 6 other ancestors2015: 13 other ancestors2014: 13 other ancestors2009: 30 other ancestors2018: 2 other ancestors2013: 16 other ancestors2012: 15 other ancestors2008: 39 other ancestors2007: 33 other ancestors2006: 40 other ancestors2005: 47 other ancestors2016: 5 other ancestors2011: 25 other ancestors2004: 58 other ancestors2003: 37 other ancestors2001: 39 other ancestors2000: 32 other ancestors1999: 20 other ancestors1998: 24 other ancestors1996: 13 other ancestors1994: 8 other ancestors2010: 29 other ancestors, 1 with a Class I recall12002: 36 other ancestors1997: 16 other ancestors1991: 1 other ancestor1995: 17 other ancestors1993: 4 other ancestors1992: 7 other ancestors1990: 3 other ancestors1985: 2 other ancestors1978: 1 other ancestor1984: 2 other ancestors1988: 2 other ancestors1987: 1 other ancestor1989: 1 other ancestor1986: 2 other ancestorsReference device: K123373 · Nautilus Spinal System · Life Spine · 2013×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012×2: 2 generations cleared close together, K131321 (2013), K132111 (2013) K141604 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K143684 · NuVasive Reline System · Nu Vasive, Incorporated · 2015K160989 · NuVasive® Reline® System · Nu Vasive, Incorporated · 2016K170126 · NuVasive® Reline® 4.5-5.0 System · Nu Vasive, Incorporated · 2017×2: 2 generations cleared close together, K182974 (2019), K191575 (2019) K200070 · ARx Spinal System · Life Spine, Inc. · 2020K203163 · ARx Illiac Spinal Screw System · Life Spine, Inc. · 202019801990200020102020
Other ancestors, by generation 1 generation back: 8 other ancestors2 generations back: 20 other ancestors3 generations back: 49 other ancestors4 generations back: 124 other ancestors5 generations back: 165 other ancestors, 1 with a Class I recall16 generations back: 98 other ancestors7 generations back: 57 other ancestors8 generations back: 35 other ancestors9 generations back: 34 other ancestors10 generations back: 14 other ancestors11 generations back: 13 other ancestors12 generations back: 13 other ancestors13 generations back: 5 other ancestors14 generations back: 4 other ancestors15 generations back: 2 other ancestors K203163 · ARx Illiac Spinal Screw System · Life Spine, Inc. · 2020K200070 · ARx Spinal System · Life Spine, Inc. · 2020K191575 · ARx Spinal System · Life Spine, Inc. · 2019K182974 · NuVasive Reline System · Nu Vasive, Incorporated · 2019K170126 · NuVasive® Reline® 4.5-5.0 System · Nu Vasive, Incorporated · 2017K160989 · NuVasive® Reline® System · Nu Vasive, Incorporated · 2016K143684 · NuVasive Reline System · Nu Vasive, Incorporated · 2015K141604 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K132111 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K131321 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−20−15−10−50
  1. Root · 23 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 19 generations between
  3. 3 generations backK191575 ARx Spinal SystemLife Spine, Inc. · 2019
  4. 2 generations backK200070 ARx Spinal SystemLife Spine, Inc. · 2020
  5. 1 generation backK203163 ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020
  6. This deviceK220025 ARx® Spinal SystemLife Spine, Inc. · 2022
Show all 23 generations
  1. Root · 23 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 22 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 21 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 20 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 19 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 18 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 17 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 16 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 15 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 14 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 13 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 12 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 11 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 10 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 9 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  16. 8 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  17. 7 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
  18. 6 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
  19. 5 generations backK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017
  20. 4 generations backK182974 NuVasive Reline SystemNu Vasive, Incorporated · 2019
  21. 3 generations backK191575 ARx Spinal SystemLife Spine, Inc. · 2019
  22. 2 generations backK200070 ARx Spinal SystemLife Spine, Inc. · 2020
  23. 1 generation backK203163 ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020
  24. This deviceK220025 ARx® Spinal SystemLife Spine, Inc. · 2022

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System5 generations back · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−23K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−22K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−21K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−20K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−19K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−18K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−17K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−16K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−15K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−14K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−13K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−12K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−11K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−10K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−9K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−8K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−7K143684NuVasive Reline SystemNu Vasive, Incorporated2015—
−6K160989NuVasive® Reline® SystemNu Vasive, Incorporated2016—
−5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated2017—
−4K182974NuVasive Reline SystemNu Vasive, Incorporated2019—
−3K191575ARx Spinal SystemLife Spine, Inc.2019—
−2K200070ARx Spinal SystemLife Spine, Inc.2020—
−1K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.2020—
0 (this device)K220025ARx® Spinal SystemLife Spine, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198420
198520
198620
198710
198820
198910
199030
199110
199270
199340
199480
1995170
1996130
1997160
1998240
1999200
2000320
2001390
2002360
2003370
2004580
2005470
2006400
2007330
2008390
2009300
2010291
2011250
2012150
2013160
2014130
2015130
201650
201760
201820
201910
202110
FIG. 1 — Lineage of K220025, 2004–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (11)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K141222Nautilus Spinal System and Solstice Oct System
Summary page 4
…l Pedicle Screw System Classification: NKB and KWP; CFR 888.3070 and CFR 888.3050; Class II Primary Predicate: Life Spine Nautilus Transition System K141222 Additional Predicate: Life Spine Conquest K090320 Zimmer Biomet Vitality+ Spinal Fixation Syste…
Life Spine, Inc.2015—
*K090320Conquest Spinal System
Summary page 4
…d KWP; CFR 888.3070 and CFR 888.3050; Class II Primary Predicate: Life Spine Nautilus Transition System K141222 Additional Predicate: Life Spine Conquest K090320 Zimmer Biomet Vitality+ Spinal Fixation System K171907 Life Spine ARx® Spin…
Life Spine2009—
*K171907Vitality® Spinal Fixation System
Summary page 4
…ine Nautilus Transition System K141222 Additional Predicate: Life Spine Conquest K090320 Zimmer Biomet Vitality+ Spinal Fixation System K171907 Life Spine ARx® Spinal System (K200070, K203163, K191575, K210549)…
Zimmer Biomet Spine, Inc.20172
*K200070ARx Spinal System
Summary page 4
…Life Spine Conquest K090320 Zimmer Biomet Vitality+ Spinal Fixation System K171907 Life Spine ARx® Spinal System (K200070, K203163, K191575, K210549) ChoiceSpine Blackbird Cervical-Thoracic Spinal…
Life Spine, Inc.2020—
*K203163ARx Illiac Spinal Screw System
Summary page 4
…ine Conquest K090320 Zimmer Biomet Vitality+ Spinal Fixation System K171907 Life Spine ARx® Spinal System (K200070, K203163, K191575, K210549) ChoiceSpine Blackbird Cervical-Thoracic Spinal Fixation…
Life Spine, Inc.2020—
*K191575ARx Spinal System
Summary page 4
…est K090320 Zimmer Biomet Vitality+ Spinal Fixation System K171907 Life Spine ARx® Spinal System (K200070, K203163, K191575, K210549) ChoiceSpine Blackbird Cervical-Thoracic Spinal Fixation System…
Life Spine, Inc.2019—
*K210549ARx Spinal System
Summary page 4
…Zimmer Biomet Vitality+ Spinal Fixation System K171907 Life Spine ARx® Spinal System (K200070, K203163, K191575, K210549) ChoiceSpine Blackbird Cervical-Thoracic Spinal Fixation System K133214 Ort…
Life Spine, Inc.2021—
*K133214Blackbird Spinal System
Summary page 4
…203163, K191575, K210549) ChoiceSpine Blackbird Cervical-Thoracic Spinal Fixation System K133214 OrthoFix Connector System K190751 Life Spine Solstice OCT System (K170804 & K143249) Device Descri…
Choicespine, LP2014—
*K190751Connector System
Summary page 4
…K210549) ChoiceSpine Blackbird Cervical-Thoracic Spinal Fixation System K133214 OrthoFix Connector System K190751 Life Spine Solstice OCT System (K170804 & K143249) Device Description: The ARX® Spinal System cons…
Orthofix, Inc.2019—
*K170804The Solstice OCT System
Summary page 4
…Cervical-Thoracic Spinal Fixation System K133214 OrthoFix Connector System K190751 Life Spine Solstice OCT System (K170804 & K143249) Device Description: The ARX® Spinal System consists of screws and longitudinal rods intended to provide temporary…
Life Spine, Inc.2017—
*K143249SOLSTICE OCT System
Summary page 4
…Thoracic Spinal Fixation System K133214 OrthoFix Connector System K190751 Life Spine Solstice OCT System (K170804 & K143249) Device Description: The ARX® Spinal System consists of screws and longitudinal rods intended to provide temporary stabilizat…
Life Spine, Inc.2015—
†K123373Nautilus Spinal SystemLife Spine2013—

Also cleared against K141222: 1 other device →

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.

  • 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 18 years and passes through 6 companies; a new generation was cleared every 7 months on median.
  • 89 of the 664 ancestors have a recall of any class; 1 has a Class I recall.
  • 1 other device also cites its predicate K141222.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The ARx® Spinal System implants are non-cervical spinal fixation devices intended for posterior spine (T1 to S2/ilium) and posterior hook fixation (T1-L5) 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…

Read the full statement (188 words)

The ARx® Spinal System implants are non-cervical spinal fixation devices intended for posterior spine (T1 to S2/ilium) and posterior hook fixation (T1-L5) 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 ARXx® 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K141222

1 other device cites the same predicate.

  • K151196Nautilus Spinal SystemLife Spine, Inc. · 2015

More from Life Spine, Inc.

85 FDA decisions under this applicant name. See the company

  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc. · 2026
  • K260837VersaLift Expandable SystemLife Spine, Inc. · 2026
  • K254274ARx® SAI Implant SystemLife Spine, Inc. · 2026
  • K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc. · 2026

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K220025 · printed Nov 6, 2026

Cite this page

510(k) Report. “K220025: 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/K220025

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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