510(k) Report

510(k) · Cleared

Cleared

ANAX™ 5.5 Spinal System

K231737510(k) SpecialCleared Oct 26, 2023134-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

Innosys Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Oct 26, 2023 as substantially equivalent to K173524 (U&I Corporation, 2017) and 6 other predicates after a 134-day review. Its family tree reaches back 9 generations to 2000. 1 later device descends from it.

Decided
Oct 26, 2023
Review
134 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
7

Its longest line of descent runs back 9 generations to K000319 (2000). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2001: 1 other ancestor2006: 1 other ancestor2000: 4 other ancestors2024: 1 descendant clearedK000319 · Ebi Xfix DFS System · Ebi, L.P. · 2000K020279 · Forex Corporation, Optima, Spinal System · Forex Corp. · 2002 · recalledK031585 · U&I, Optima, Spinal System · U&I Corp., America · 2003 · recalledK053573 · GSS Pedicle Screw System · GS Medical Co., Ltd. · 2006K100765 · Fixpine II System · Dio Medical Co., Ltd. · 2010K132101 · Anax 5.5 Spinal System · U&I Corporation · 2013K143417 · ANAX 5.5 Spinal System · U&I Corporation · 2015K162189 · ANAX™ 5.5 Spinal System · U&I Corporation · 2016K173524 · ANAX 5.5™ Spinal System · U&I Corporation · 2017 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 1 descendant K173524 · ANAX 5.5™ Spinal System · U&I Corporation · 2017 · recalledK162189 · ANAX™ 5.5 Spinal System · U&I Corporation · 2016K143417 · ANAX 5.5 Spinal System · U&I Corporation · 2015K132101 · Anax 5.5 Spinal System · U&I Corporation · 2013K100765 · Fixpine II System · Dio Medical Co., Ltd. · 2010K053573 · GSS Pedicle Screw System · GS Medical Co., Ltd. · 2006K031585 · U&I, Optima, Spinal System · U&I Corp., America · 2003 · recalledK020279 · Forex Corporation, Optima, Spinal System · Forex Corp. · 2002 · recalledK000319 · Ebi Xfix DFS System · Ebi, L.P. · 2000−50
  1. Root · 9 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
  2. 5 generations between
  3. 3 generations backK143417 ANAX 5.5 Spinal SystemU&I Corporation · 2015
  4. 2 generations backK162189 ANAX™ 5.5 Spinal SystemU&I Corporation · 2016
  5. 1 generation backK173524 ANAX 5.5™ Spinal SystemU&I Corporation · 2017 · Recalled
  6. This deviceK231737 ANAX™ 5.5 Spinal SystemInnosys Co., Ltd. · 2023
  7. Descendant · cites it directly · 0 of its ownK233960 INNOVERSE Spinal SystemInnosys Co., Ltd. · 2024
Show all 9 generations
  1. Root · 9 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
  2. 8 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
  3. 7 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
  4. 6 generations backK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
  5. 5 generations backK100765 Fixpine II SystemDio Medical Co., Ltd. · 2010
  6. 4 generations backK132101 Anax 5.5 Spinal SystemU&I Corporation · 2013
  7. 3 generations backK143417 ANAX 5.5 Spinal SystemU&I Corporation · 2015
  8. 2 generations backK162189 ANAX™ 5.5 Spinal SystemU&I Corporation · 2016
  9. 1 generation backK173524 ANAX 5.5™ Spinal SystemU&I Corporation · 2017 · Recalled
  10. This deviceK231737 ANAX™ 5.5 Spinal SystemInnosys Co., Ltd. · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K233960INNOVERSE Spinal SystemInnosys Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K000319Ebi Xfix DFS SystemEbi, L.P.2000—
−8K020279Forex Corporation, Optima, Spinal SystemForex Corp.20024
−7K031585U&I, Optima, Spinal SystemU&I Corp., America20035
−6K053573GSS Pedicle Screw SystemGS Medical Co., Ltd.2006—
−5K100765Fixpine II SystemDio Medical Co., Ltd.2010—
−4K132101Anax 5.5 Spinal SystemU&I Corporation2013—
−3K143417ANAX 5.5 Spinal SystemU&I Corporation2015—
−2K162189ANAX™ 5.5 Spinal SystemU&I Corporation2016—
−1K173524ANAX 5.5™ Spinal SystemU&I Corporation20171
0 (this device)K231737ANAX™ 5.5 Spinal SystemInnosys Co., Ltd.2023—
+1K233960INNOVERSE Spinal SystemInnosys Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200040
200110
200310
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
FIG. 1 — Lineage of K231737, 2000–2024Source: 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.

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. #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? (7)

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
*K173524ANAX 5.5™ Spinal System
Summary page 4
…per 21 CFR 888.3070 Common Name: Thoracolumbosacral Pedicle Screw System Product Code: NKB Primary Predicate ANAXTM 5.5 Spinal System (K173524, K162189, K143417, K132101) Device: Additional Predicates: OPTIMA™ Spinal System(K024096) Synergy™ Spinal…
U&I Corporation20171
*K162189ANAX™ 5.5 Spinal System
Summary page 4
…CFR 888.3070 Common Name: Thoracolumbosacral Pedicle Screw System Product Code: NKB Primary Predicate ANAXTM 5.5 Spinal System (K173524, K162189, K143417, K132101) Device: Additional Predicates: OPTIMA™ Spinal System(K024096) Synergy™ Spinal System -…
U&I Corporation2016—
*K143417ANAX 5.5 Spinal System
Summary page 4
…070 Common Name: Thoracolumbosacral Pedicle Screw System Product Code: NKB Primary Predicate ANAXTM 5.5 Spinal System (K173524, K162189, K143417, K132101) Device: Additional Predicates: OPTIMA™ Spinal System(K024096) Synergy™ Spinal System - Synergy…
U&I Corporation2015—
*K132101Anax 5.5 Spinal System
Summary page 4
…on Name: Thoracolumbosacral Pedicle Screw System Product Code: NKB Primary Predicate ANAXTM 5.5 Spinal System (K173524, K162189, K143417, K132101) Device: Additional Predicates: OPTIMA™ Spinal System(K024096) Synergy™ Spinal System - Synergy VLS Screw…
U&I Corporation2013—
*K024096Optima, Spinal System
Summary page 4
…roduct Code: NKB Primary Predicate ANAXTM 5.5 Spinal System (K173524, K162189, K143417, K132101) Device: Additional Predicates: OPTIMA™ Spinal System(K024096) Synergy™ Spinal System - Synergy VLS Screw(K011437) Fixpine II System(K100765) De…
U&I Corp., America20033
*K011437Synergy 4.0 MM, 4.5 MM VLS Screws
Summary page 4
…tem (K173524, K162189, K143417, K132101) Device: Additional Predicates: OPTIMA™ Spinal System(K024096) Synergy™ Spinal System - Synergy VLS Screw(K011437) Fixpine II System(K100765) Description of Device: The ANAXTM 5.5 Spinal System is manufactured by Innosy…
Interpore Cross Intl.2001—
*K100765Fixpine II System
Summary page 4
…Additional Predicates: OPTIMA™ Spinal System(K024096) Synergy™ Spinal System - Synergy VLS Screw(K011437) Fixpine II System(K100765) Description of Device: The ANAXTM 5.5 Spinal System is manufactured by Innosys Co., Ltd.. The ANAXTM 5.5 Spinal System is a top…
Dio Medical Co., Ltd.2010—

Also cleared against K173524: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K233960INNOVERSE Spinal SystemInnosys Co., Ltd.20240

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 23 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
  • 4 of the 16 ancestors have a recall of any class.
  • Of its descendants, K233960 (Innosys Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K173524.

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. 2023, 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 ANAX™ 5.5 SPINAL SYSTEM is a posterior, non cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• Spondylolisthesis (Grade 3 and 4)

• Degenerative spondylolisthesis with objective evidence of neurological impairment

• Trauma (i.e., fracture or dislocation)

• Spinal stenosis

• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)

• Tumor

• Pseudoarthrosis

• Failed previous fusion

Indications for use as stated in the FDA summary.

Also cleared against K173524

1 other device cites the same predicate.

  • K233960INNOVERSE Spinal SystemInnosys Co., Ltd. · 2024

More from Innosys Co., Ltd.

4 FDA decisions under this applicant name. See the company

  • K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd. · 2024
  • K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd. · 2024
  • K233960INNOVERSE Spinal SystemInnosys Co., Ltd. · 2024

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/K231737 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231737: ANAX™ 5.5 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/K231737

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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