510(k) Report

510(k) · Cleared

Cleared

Acrosspine Pedicle Screw System

K141695510(k) TraditionalCleared Dec 30, 2014189-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

Arthro-Dif · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Dec 30, 2014 as substantially equivalent to K073126 (Depuy Spine, Inc., 2007) and 3 other predicates after a 189-day review. Its family tree reaches back 5 generations to 1995.

Decided
Dec 30, 2014
Review
189 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K944736 (1995). 41 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2009: 1 other ancestor2008: 1 other ancestor2007: 2 other ancestors2006: 2 other ancestors2005: 3 other ancestors2004: 3 other ancestors2003: 2 other ancestors2002: 4 other ancestors1997: 1 other ancestor2000: 7 other ancestors1998: 3 other ancestors1996: 2 other ancestors2001: 2 other ancestors1999: 2 other ancestorsK944736 · VSP (Variable Screw Placement) · Acromed Corp. · 1995K981274 · Acromed Timx Plate Based Low Back System · Acromed Corp. · 1998K010576 · Monarch Spine System · Depuyacromed · 2001K024348 · Monarch Spine System · Depuyacromed · 2003K073126 · Expedium Spine System · Depuy Spine, Inc. · 200719952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 11 other ancestors3 generations back: 9 other ancestors4 generations back: 11 other ancestors5 generations back: 2 other ancestors K073126 · Expedium Spine System · Depuy Spine, Inc. · 2007K024348 · Monarch Spine System · Depuyacromed · 2003K010576 · Monarch Spine System · Depuyacromed · 2001K981274 · Acromed Timx Plate Based Low Back System · Acromed Corp. · 1998K944736 · VSP (Variable Screw Placement) · Acromed Corp. · 1995−50
  1. Root · 5 generations backK944736 VSP (Variable Screw Placement)Acromed Corp. · 1995
  2. 4 generations backK981274 Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
  3. 3 generations backK010576 Monarch Spine SystemDepuyacromed · 2001
  4. 2 generations backK024348 Monarch Spine SystemDepuyacromed · 2003
  5. 1 generation backK073126 Expedium Spine SystemDepuy Spine, Inc. · 2007
  6. This deviceK141695 Acrosspine Pedicle Screw SystemArthro-Dif · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K944736VSP (Variable Screw Placement)Acromed Corp.1995—
−4K981274Acromed Timx Plate Based Low Back SystemAcromed Corp.1998—
−3K010576Monarch Spine SystemDepuyacromed2001—
−2K024348Monarch Spine SystemDepuyacromed2003—
−1K073126Expedium Spine SystemDepuy Spine, Inc.2007—
0 (this device)K141695Acrosspine Pedicle Screw SystemArthro-Dif2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199710
199830
199920
200070
200120
200240
200320
200430
200530
200620
200720
200810
200910
201010
FIG. 1 — Lineage of K141695, 1995–2014Source: 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K073126Expedium Spine System
Summary page 4
…nd straight rods from 150- 300mm. Predicate Device(s): The Arthro-DIF Acrosspine Pedicle Screw System is substantially equivalent to the Expedium System by DePuy Spine (K073126), the S4 System by Aesculap (K090657), the…
Depuy Spine, Inc.2007—
*K090657Modification to: S4 Spinal System
Summary page 4
…edicate Device(s): The Arthro-DIF Acrosspine Pedicle Screw System is substantially equivalent to the Expedium System by DePuy Spine (K073126), the S4 System by Aesculap (K090657), the K141695 - page 2 of 2 Eas…
Aesculap Implant Systems2009—
*K082592LDR Spine Easyspine System
Summary page 5
…lap (K090657), the K141695 - page 2 of 2 Easyspine system by LDR Spine (K082592) and the AnyPlus Spinal System by GS Medical (K091717 - Primary Predicate). Performance Standards: Pre-clinical testing was perf…
Ldr Spine USA2008—
*K091717Any Plus Spinal Fixation System
Summary page 5
…K141695 - page 2 of 2 Easyspine system by LDR Spine (K082592) and the AnyPlus Spinal System by GS Medical (K091717 - Primary Predicate). Performance Standards: Pre-clinical testing was performed on the Arthro-Dif Acrosspine Pedicle Screw Syste…
GS Medical Co., Ltd.2010—

Also cleared against K073126: 6 other devices →

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 19 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
  • 5 of the 41 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K073126.

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. 2014, 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 Acrosspine Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion 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;

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 K073126

6 other devices cite the same predicate.

  • K243249TriALTIS™ Spine SystemMedos International SARL · 2025
  • K130291S4 Spinal SystemAesculap Implant System, Inc. · 2013
  • K123352S4 Spinal SystemAesculap Implant Systems, Inc. · 2012
  • K090799Modification to Expedium Spine SystemDepuy Spine, Inc. · 2009
  • K081898Expedium Spine SystemDepuy Spine, Inc. · 2008
  • K082195Modifications to Expedium Spine SystemDepuy Spine, Inc. · 2008

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/K141695 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141695: Acrosspine Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141695

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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