510(k) Report

510(k) · Cleared

Cleared

TSRH Variable Angle Sacral Screw

K904243510(k) TraditionalCleared Jan 22, 1992495-day reviewClass II21 CFR 888.3050

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

Danek Medical, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jan 22, 1992 after a 495-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
Jan 22, 1992
Review
495 days
Class
Class II
Product code
KWP
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 deviceK904243 TSRH Variable Angle Sacral ScrewDanek Medical, Inc. · 1992
  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)K904243TSRH Variable Angle Sacral ScrewDanek Medical, Inc.1992—
+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 K904243, 1992–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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 KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

More from Danek Medical, Inc.

56 FDA decisions under this applicant name. See the company

  • K994122Bone Graft Washer, Model 9090114 - 9090118Danek Medical, Inc. · 2000
  • K993810CD Horizon Spinal SystemDanek Medical, Inc. · 2000
  • K993855Atlantis Anterior Cervical Plate SystemDanek Medical, Inc. · 1999
  • K991528Modification to Tenor Spinal System-Rod/Bolt ConnectorDanek Medical, Inc. · 1999
  • K990603Modification of the Zplate-Atl Anterior Fixation SystemDanek Medical, Inc. · 1999

Recent decisions in KWP

The KWP category page

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  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
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https://510kreport.com/device/K904243 · printed Nov 4, 2026

Cite this page

510(k) Report. “K904243: TSRH Variable Angle Sacral Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904243

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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