510(k) Report

510(k) · Cleared

Cleared

FMS Arthro-Cutter

K951701510(k) TraditionalCleared May 9, 199527-day reviewClass I21 CFR 886.4350

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

Future Medical Systems, Inc. · HNX Depressor, Orbital

Cleared on May 9, 1995 after a 27-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 9, 1995
Review
27 days
Class
Class I
Product code
HNX
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K951701Source: 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 HNX? 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 lists a 510(k) statement for it but has not posted the file, 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 HNX devices

HNX Depressor, Orbital: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HNX

FDA has decided no HNX device since 2007.

Median 510(k) review, days · HNX

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

Recalls per year · HNX

No recall names HNX since 2007.

Adverse event reports per year · HNX

6in 2019

2011: 22012: 12018: 12019: 6
2007high 6 (2019) · low 0 (2007)2025

MAUDE reports naming product code HNX, 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—00
20080—00
20090—00
20100—00
20110—02
20120—01
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20190—06
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Future Medical Systems, Inc.

12 FDA decisions under this applicant name. See the company

  • K023963Adhoc ClawFuture Medical Systems, Inc. · 2003
  • K021030Titanium Cannulated Interference ScrewFuture Medical Systems, Inc. · 2002
  • K013685Plla Cannulated Interference ScrewFuture Medical Systems, Inc. · 2002
  • K002040FMS SoloFuture Medical Systems, Inc. · 20001 recall
  • K980808Endo FMS UrologyFuture Medical Systems, Inc. · 1998

Recent decisions in HNX

The HNX category page

  • K951702FMS High Flow Arthro-SheathFuture Medical Systems, Inc. · 1995

https://510kreport.com/device/K951701 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951701: FMS Arthro-Cutter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951701

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