510(k) Report

510(k) · Cleared

Cleared

Laminectomy Rogeur

K902819510(k) TraditionalCleared Aug 9, 199043-day reviewClass I21 CFR 888.4540

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

Ruggles Corp. · LXH Orthopedic Manual Surgical Instrument

Cleared on Aug 9, 1990 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.

Decided
Aug 9, 1990
Review
43 days
Class
Class I
Product code
LXH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2010: 1 descendant cleared2016: 4 descendants cleared2013: 2 descendants cleared2015: 1 descendant cleared2020: 2 descendants cleared2018: 1 descendant cleared2026: 1 descendant cleared2022: 2 descendants cleared2025: 1 descendant cleared2021: 1 descendant cleared2023: 2 descendants cleared1990200020102020
  1. This deviceK902819 Laminectomy RogeurRuggles Corp. · 1990
  2. Descendant · cites it directly · 17 of its ownK092227 Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison…Integra Lifesciences Corp. · 2010
  3. Descendant · 2 generations on · 10 of its ownK150428 Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles…Integra Lifesciences Corp. · 2015
  4. Descendant · 2 generations on · 7 of its ownK153243 Fehling-PunchesFehling Instruments GmbH & Co. KG · 2016
  5. Descendant · 3 generations on · 2 of its ownK200768 Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG · 2021
  6. Descendant · 3 generations on · 1 of its ownK223596 SQ.line KERRISONAesculap, Inc. · 2023

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2010: 12013: 22015: 12016: 42018: 12020: 22021: 12022: 22023: 22025: 12026: 1
2010high 4 (2016) · low 0 (2011)2026

Most influential descendants

Showing 5 of 18 · See all
  • K092227Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison RongeursIntegra Lifesciences Corp. · 2010 · cites it directly17descendants
  • K150428Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison…Integra Lifesciences Corp. · 2015 · 2 generations on10descendants
  • K153243Fehling-PunchesFehling Instruments GmbH & Co. KG · 2016 · 2 generations on7descendants
  • K200768Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG · 2021 · 3 generations on2descendants
  • K223596SQ.line KERRISONAesculap, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K902819Laminectomy RogeurRuggles Corp.1990—
+1K092227Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison RongeursIntegra Lifesciences Corp.2010—
+2K150428Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM)…Integra Lifesciences Corp.2015—
+2K153243Fehling-PunchesFehling Instruments GmbH & Co. KG2016—
+3K200768Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG2021—
+3K223596SQ.line KERRISONAesculap, Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201320
201510
201640
201810
202020
202110
202220
202320
202510
202610
FIG. 1 — Lineage of K902819, 1990–2026Source: 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 LXH? 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? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K092227Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison RongeursIntegra Lifesciences Corp.201017

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, K092227 (Integra Lifesciences Corp., 2010) has gone furthest, with 17 descendants of its own.

How does its category compare?

All LXH devices

LXH Orthopedic Manual Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXH

1in 2019

2010: 12014: 12019: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXH

Too few LXH 510(k)s in any year since 2007 to give a median.

Recalls per year · LXH

3in 2024

2007: 412008: 412009: 252010: 542011: 122012: 292013: 172014: 122015: 72016: 92017: 142018: 232019: 102020: 32021: 22022: 42023: 42024: 32026 (partial year): 8
2007high 54 (2010) · low 0 (2025)2026

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

Adverse event reports per year · LXH

6,119in 2025

2007: 3982008: 8332009: 1,5692010: 2,3292011: 2,4882012: 2,0592013: 4,1492014: 3,8442015: 5,9442016: 6,3652017: 4,1332018: 4,6852019: 5,2242020: 4,7662021: 4,8322022: 4,8442023: 5,1632024: 6,3192025: 6,119
2007high 6,365 (2016) · low 398 (2007)2025

MAUDE reports naming product code LXH, 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
20070—41398
20080—41833
20090—251,569
20101—542,329
20110—122,488
20120—292,059
20130—174,149
20141—123,844
20150—75,944
20160—96,365
20170—144,133
20180—234,685
20191—105,224
20200—34,766
20210—24,832
20220—44,844
20230—45,163
20240—36,319
20250—06,119
20260—8—

More from Ruggles Corp.

5 FDA decisions under this applicant name. See the company

  • K903485Titanium MeshRuggles Corp. · 1991
  • K902818Multiple Nonpowered Neurosurgical InstrumentRuggles Corp. · 19901 recall
  • K902850Zeppelin InstrumentsRuggles Corp. · 1990
  • K893415Trans-Oral Depth GaugeRuggles Corp. · 1989

Recent decisions in LXH

The LXH category page

  • K192873SX-One MicroKnifeSonex Health, Inc. · 20191 recall
  • K140414Imbibe NeedleOrthovita, Inc. · 20141 recall
  • K101609Self Retaining Soft Tissue RetractorKoros USA, Inc. · 2010
  • K001507Microperforation InstrumentSmith & Nephew, Inc. · 2000
  • K952495Anchors Away Soft Tissue Attachment SystemOrthopedic Systems, Inc. · 1996

https://510kreport.com/device/K902819 · printed Nov 6, 2026

Cite this page

510(k) Report. “K902819: Laminectomy Rogeur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902819

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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