510(k) Report

510(k) · Cleared

Cleared

Bow & Arrow Drill Guide

K882407510(k) TraditionalCleared Sep 6, 198888-day reviewClass I21 CFR 878.4820

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

Instrument Makar, Inc. · LXI Guide, Drill, Ligament

Cleared on Sep 6, 1988 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 6, 1988
Review
88 days
Class
Class I
Product code
LXI
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K882407Source: FDA 510(k) database · 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 LXI? 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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All LXI devices

LXI Guide, Drill, Ligament: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXI

FDA has decided no LXI device since 2007.

Median 510(k) review, days · LXI

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

Recalls per year · LXI

No recall names LXI since 2007.

Adverse event reports per year · LXI

3in 2022

2007: 142008: 42009: 112010: 72011: 22014: 12015: 22016: 22020: 12022: 3
2007high 14 (2007) · low 0 (2012)2025

MAUDE reports naming product code LXI, 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—014
20080—04
20090—011
20100—07
20110—02
20120—00
20130—00
20140—01
20150—02
20160—02
20170—00
20180—00
20190—00
20200—01
20210—00
20220—03
20230—00
20240—00
20250—00
20260—0—

More from Instrument Makar, Inc.

28 FDA decisions under this applicant name. See the company

  • K002600Litwin Cruicate AnchorInstrument Makar, Inc. · 2000
  • K980999ST Leger Cemented Semi-Constrained Total Knee ImplantInstrument Makar, Inc. · 1998
  • K963396Biosphere Suture AnchorInstrument Makar, Inc. · 1997
  • K964364Disposable ApronInstrument Makar, Inc. · 1997
  • K955835Fluid Barrier Boot Knee & Ankle-HighInstrument Makar, Inc. · 1996

Recent decisions in LXI

The LXI category page

  • K930573Synvasive Ceramic Sutting BlockSynvasive Technology, Inc. · 1994
  • K910712Villan (Video Lift Link Analysis)Physio Systems, Inc. · 1991
  • K892655Acl Drill Guide SystemBaxter Healthcare Corp · 1989
  • K890445Personal Alert Assist DeviceSilent Call Corp. · 1989
  • K881378Pfizer Hospital Products Group Acl Drill GuidePfizer, Inc. · 1988

https://510kreport.com/device/K882407 · printed Nov 6, 2026

Cite this page

510(k) Report. “K882407: Bow & Arrow Drill Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882407

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