510(k) Report

510(k) · Cleared

Cleared

Modification to Xia 4.5 Spinal System

K060748510(k) SpecialCleared Apr 13, 200623-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

Stryker Spine · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Apr 13, 2006 as substantially equivalent to K050461 (Stryker Spine, 2005) and 5 other predicates after a 23-day review. Its family tree reaches back 4 generations to 1995. 134 later devices descend from it.

Decided
Apr 13, 2006
Review
23 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K950697 (1995). 12 ancestors in all. 134 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1997: 1 other ancestor2005: 1 other ancestor2003: 2 other ancestors2000: 1 other ancestor2001: 2 other ancestors2018: 9 descendants cleared2016: 2 descendants cleared2014: 3 descendants cleared2013: 2 descendants cleared2015: 4 descendants cleared2009: 1 descendant cleared2011: 3 descendants cleared2012: 4 descendants cleared2017: 9 descendants cleared2023: 21 descendants cleared2021: 5 descendants cleared2024: 23 descendants cleared2022: 8 descendants cleared2020: 8 descendants cleared2019: 4 descendants cleared2025: 14 descendants cleared2026: 14 descendants clearedK950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 1995×2: 2 generations cleared close together, K050461 (2005), K052761 (2005) K060361 · Xia Spinal System, Xia 4.5 Spinal System · Stryker Spine · 2006 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors 1 generation forward: 9 descendants2 generations forward: 23 descendants3 generations forward: 37 descendants4 generations forward: 30 descendants5 generations forward: 16 descendants6 generations forward: 10 descendants7 generations forward: 6 descendants8 generations forward: 3 descendants K060361 · Xia Spinal System, Xia 4.5 Spinal System · Stryker Spine · 2006 · recalledK052761 · Modification to: Xia 4.5 Spinal System · Stryker Spine · 2005K050461 · Xia 4.5 Spinal System · Stryker Spine · 2005K950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 19950+5
  1. Root · 4 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
  2. 3 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
  3. 2 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
  4. 1 generation backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
  5. This deviceK060748 Modification to Xia 4.5 Spinal SystemStryker Spine · 2006
  6. Descendant · cites it directly · 98 of its ownK092605 Xia 4.5 Spinal SystemStryker Spine · 2009
  7. Descendant · 2 generations on · 88 of its ownK121342 Xia 4.5 Spinal SystemStryker Corp. · 2012
  8. Descendant · cites it directly · 84 of its ownK133188 Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio &…Stryker Spine · 2013
  9. Descendant · 2 generations on · 83 of its ownK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  10. Descendant · 2 generations on · 34 of its ownK111478 Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation · 2011

Showing 5 of 134 descendants. See all descendants

Descendants cleared per year

2009: 12011: 32012: 42013: 22014: 32015: 42016: 22017: 92018: 92019: 42020: 82021: 52022: 82023: 212024: 232025: 142026: 14
2009high 23 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 134 · See all
  • K092605Xia 4.5 Spinal SystemStryker Spine · 2009 · cites it directly98descendants
  • K121342Xia 4.5 Spinal SystemStryker Corp. · 2012 · 2 generations on88descendants
  • K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine · 2013 · cites it directly84descendants
  • K142381Xia 3 Spinal SystemStryker Corp. · 2014 · 2 generations on83descendants
  • K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation · 2011 · 2 generations on34descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K950697Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech1995—
−3K050461Xia 4.5 Spinal SystemStryker Spine2005—
−2K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005—
−1K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20061
0 (this device)K060748Modification to Xia 4.5 Spinal SystemStryker Spine2006—
+1K092605Xia 4.5 Spinal SystemStryker Spine2009—
+2K121342Xia 4.5 Spinal SystemStryker Corp.2012—
+1K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal…Stryker Spine2013—
+2K142381Xia 3 Spinal SystemStryker Corp.2014—
+2K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
200120
200210
200320
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201130
201240
201320
201430
201540
201620
201790
201890
201940
202080
202150
202280
2023210
2024230
2025140
2026140
FIG. 1 — Lineage of K060748, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (6)

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
*K050461Xia 4.5 Spinal System
Summary page 1
…21 CFR §888.3070(b)(1) and (b)(2) Device Product Code: NKB, KWP, KWQ, MNH, and MNI Predicate Device Information: K050461, K052761, K060361 - Stryker Spine Xia? 4.5 Spinal System…
Stryker Spine2005—
*K052761Modification to: Xia 4.5 Spinal System
Summary page 1
…R §888.3070(b)(1) and (b)(2) Device Product Code: NKB, KWP, KWQ, MNH, and MNI Predicate Device Information: K050461, K052761, K060361 - Stryker Spine Xia? 4.5 Spinal System…
Stryker Spine2005—
*K060361Xia Spinal System, Xia 4.5 Spinal System
Summary page 1
…70(b)(1) and (b)(2) Device Product Code: NKB, KWP, KWQ, MNH, and MNI Predicate Device Information: K050461, K052761, K060361 - Stryker Spine Xia? 4.5 Spinal System…
Stryker Spine20061
*K962628Moss Miami Spinal System
Summary page 1
…K050461, K052761, K060361 - Stryker Spine Xia? 4.5 Spinal System K962628 - DePuy Spine MOSS Miami TM 4.0 Spinal System…
Depuy, Inc.1997—
*K950697Depuy Motech Moss Miami Spinal System - Pedicle Fixation
Summary page 1
…K962628 - DePuy Spine MOSS Miami TM 4.0 Spinal System K950697 - Moss Miami 5.0 Spinal System K020709 - CD Legacy 4.5 Spinal System…
Depuy Motech1995—
*K020709Modification to CD Horizon Spinal System
Summary page 1
…Spinal System K950697 - Moss Miami 5.0 Spinal System K020709 - CD Legacy 4.5 Spinal System…
Medtronic Sofamor Danek2002—

Also cleared against K050461: 11 other devices →

What descends from it? (134)

See all 134

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092605Xia 4.5 Spinal SystemStryker Spine200998
K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384
K132603Apex Spine SystemSpinecraft, LLC201325
K150417Astra Spine SystemSpinecraft, LLC201521
K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410
K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188
K143683APEX-DL Spine SystemSpinecraft, LLC20153
K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143
K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162

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 11 years and passes through 2 companies; a new generation was cleared every 5 months on median.
  • 1 of the 12 ancestors has a recall of any class.
  • Of its descendants, K092605 (Stryker Spine, 2009) has gone furthest, with 98 descendants of its own.
  • 11 other devices also cite its predicate K050461.

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.

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 Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation 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, pseudoarthrosis and failed previous fusion.

The Stryker Spine DIAPASONTM Spinal System, Opus TM Spinal System and XIA® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

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 K050461

11 other devices cite the same predicate.

  • K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc. · 2018
  • K151362HC Spinal SystemHung Chun Bio-S Co., Ltd. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016
  • K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2014
  • K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC · 2014
  • K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio…Stryker Spine · 2013

More from Stryker Spine

92 FDA decisions under this applicant name. See the company

  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System…Stryker Spine · 2024
  • K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2024
  • K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA®…Stryker Spine · 2023

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/K060748 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060748: Modification to Xia 4.5 Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060748

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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