510(k) Report

510(k) · Cleared

Cleared

Crosslink Axial and Offset Plates

K923242510(k) TraditionalCleared May 19, 1993321-day reviewClass II21 CFR 888.3060

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

Sofamor Danek Mfg., Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on May 19, 1993 after a 321-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 580 later devices descend from it.

Decided
May 19, 1993
Review
321 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

580 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2018: 34 descendants cleared2012: 19 descendants cleared2010: 11 descendants cleared2011: 17 descendants cleared2025: 49 descendants cleared2014: 24 descendants cleared1998: 5 descendants cleared2009: 6 descendants cleared2015: 23 descendants cleared1999: 3 descendants cleared2017: 31 descendants cleared2013: 22 descendants cleared2006: 5 descendants cleared2007: 7 descendants cleared2008: 8 descendants cleared2024: 48 descendants cleared2022: 34 descendants cleared2023: 49 descendants cleared2019: 25 descendants cleared2020: 39 descendants cleared2016: 28 descendants cleared2021: 32 descendants cleared2000: 3 descendants cleared2005: 3 descendants cleared2004: 6 descendants cleared2002: 2 descendants cleared2001: 1 descendant cleared2026: 44 descendants cleared2003: 1 descendant cleared1990200020102020
  1. This deviceK923242 Crosslink Axial and Offset PlatesSofamor Danek Mfg., Inc. · 1993
  2. Descendant · cites it directly · 579 of its ownK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
  3. Descendant · 2 generations on · 529 of its ownK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
  4. Descendant · 2 generations on · 311 of its ownK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
  5. Descendant · 2 generations on · 251 of its ownK982914 Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998
  6. Descendant · 2 generations on · 251 of its ownK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998

Showing 5 of 580 descendants. See all descendants

Descendants cleared per year

1997: 11998: 51999: 32000: 32001: 12002: 22003: 12004: 62005: 32006: 52007: 72008: 82009: 62010: 112011: 172012: 192013: 222014: 242015: 232016: 282017: 312018: 342019: 252020: 392021: 322022: 342023: 492024: 482025: 492026: 44
1997high 49 (2023) · low 1 (1997)2026

Most influential descendants

Showing 5 of 580 · See all
  • K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997 · cites it directly579descendants
  • K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy…Cross Medical Products, Inc. · 1998 · 2 generations on529descendants
  • K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…Cross Medical Products, Inc. · 1998 · 2 generations on311descendants
  • K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998 · 2 generations on251descendants
  • K980484Aesculap Spine System EvolutionAesculap, Inc. · 1998 · 2 generations on251descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923242Crosslink Axial and Offset PlatesSofamor Danek Mfg., Inc.1993—
+1K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc.1997—
+2K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross…Cross Medical Products, Inc.1998—
+2K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy…Cross Medical Products, Inc.1998—
+2K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc.1998—
+2K980484Aesculap Spine System EvolutionAesculap, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199850
199930
200030
200110
200220
200310
200460
200530
200650
200770
200880
200960
2010110
2011170
2012190
2013220
2014240
2015230
2016280
2017310
2018340
2019250
2020390
2021320
2022340
2023490
2024480
2025490
2026440
FIG. 1 — Lineage of K923242, 1993–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWQ? 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 KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (580)

See all 580

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

NumberDeviceApplicantDecidedDescendants
K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc.1997579

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?

  • Of its descendants, K950099 (Buckman Co., Inc., 1997) has gone furthest, with 579 descendants of its own.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

More from Sofamor Danek Mfg., Inc.

23 FDA decisions under this applicant name. See the company

  • K936294Sentry (TM) Anterior/Posterior Spinal SystemsSofamor Danek Mfg., Inc. · 1995
  • K930191Danek (TM) Spinal Epidural Endoscopic SYSofamor Danek Mfg., Inc. · 1995
  • K932029TSRH Spinal ScrewsSofamor Danek Mfg., Inc. · 1995
  • K922486Danek Tissue Cutting and Removal SystemSofamor Danek Mfg., Inc. · 1993
  • K930807Sentry Anterior Spinal SystemSofamor Danek Mfg., Inc. · 1993

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The KWQ category page

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https://510kreport.com/device/K923242 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923242: Crosslink Axial and Offset Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923242

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026