510(k) Report

510(k) · Cleared

Cleared

Synthes Spinal Implant System

K802462510(k) TraditionalCleared Dec 16, 198069-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

Synthes (Usa) · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Dec 16, 1980 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 697 devices in its family, counting itself, has a Class I recall. 696 later devices descend from it.

Decided
Dec 16, 1980
Review
69 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

696 later devices descend from it, 2 citing it directly. 1 of the 697 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2004: 2 descendants cleared2005: 1 descendant cleared2010: 8 descendants cleared2015: 16 descendants cleared2006: 1 descendant cleared2019: 47 descendants cleared2007: 1 descendant cleared2012: 5 descendants cleared2020: 63 descendants cleared2018: 35 descendants cleared2021: 65 descendants cleared, 1 with a Class I recall12014: 13 descendants cleared2008: 1 descendant cleared2017: 42 descendants cleared2013: 10 descendants cleared2023: 80 descendants cleared2011: 10 descendants cleared2016: 24 descendants cleared2022: 65 descendants cleared2024: 74 descendants cleared2025: 68 descendants cleared2026: 65 descendants cleared19801990200020102020
  1. This deviceK802462 Synthes Spinal Implant SystemSynthes (Usa) · 1980
  2. Descendant · cites it directly · 694 of its ownK042499 Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
  3. Descendant · 2 generations on · 677 of its ownK042922 Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004
  4. Descendant · 3 generations on · 669 of its ownK061274 Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006
  5. Descendant · 4 generations on · 637 of its ownK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
  6. Descendant · 5 generations on · 397 of its ownK094042 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010

Showing 5 of 696 descendants. See all descendants

Descendants cleared per year

2004: 22005: 12006: 12007: 12008: 12010: 82011: 102012: 52013: 102014: 132015: 162016: 242017: 422018: 352019: 472020: 632021: 652022: 652023: 802024: 742025: 682026: 65
2004high 80 (2023) · low 0 (2009)2026

Class I recalls in this family

  • K211616 ExcelsiusHub9 generations on · 2021

Most influential descendants

Showing 5 of 696 · See all
  • K042499Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004 · cites it directly694descendants
  • K042922Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004 · 2 generations on677descendants
  • K061274Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006 · 3 generations on669descendants
  • K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008 · 4 generations on637descendants
  • K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010 · 5 generations on397descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K802462Synthes Spinal Implant SystemSynthes (Usa)1980—
+1K042499Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek2004—
+2K042922Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc.2004—
+3K061274Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek2006—
+4K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008—
+5K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200510
200610
200710
200810
201080
2011100
201250
2013100
2014130
2015160
2016240
2017420
2018350
2019470
2020630
2021651
2022650
2023800
2024740
2025680
2026650
FIG. 1 — Lineage of K802462, 1980–2026Source: 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.

1 device in this family has a Class I recall. 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
Get a 510(k) Report

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? (696)

See all 696

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

NumberDeviceApplicantDecidedDescendants
K042499Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek2004694
K051039Basis Spinal SystemMedtronic Sofamor Danek USA, Inc.20050

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 9 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K042499 (Medtronic Sofamor Danek, 2004) has gone furthest, with 694 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 Synthes (Usa)

406 FDA decisions under this applicant name. See the company

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  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K802462 · printed Nov 6, 2026

Cite this page

510(k) Report. “K802462: Synthes Spinal Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K802462

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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