510(k) Report

510(k) · Cleared

Cleared

Orthomet LHMC Femoral Stem

K931678510(k) TraditionalCleared Oct 14, 1994556-day reviewClass II21 CFR 886.1510

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

Orthomet, Inc. · HMC Monitor, Eye Movement, Diagnostic

Cleared on Oct 14, 1994 after a 556-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 14, 1994
Review
556 days
Class
Class II
Product code
HMC
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K931678Source: 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.

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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 HMC devices

HMC Monitor, Eye Movement, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HMC

FDA has decided no HMC device since 2007.

Median 510(k) review, days · HMC

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

Recalls per year · HMC

No recall names HMC since 2007.

Adverse event reports per year · HMC

No MAUDE report names HMC since 2007.

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—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Orthomet, Inc.

60 FDA decisions under this applicant name. See the company

  • K936310Orthomet HMC Femoral Stem ComponentOrthomet, Inc. · 1995
  • K945783Orthomet Titanium Hybrid Femoral StemOrthomet, Inc. · 1995
  • K943873Orthomet Anatomically Guided Carpal Tunnel Release SYOrthomet, Inc. · 1995
  • K944752Orthomet Resurfacing Femoral ComponentOrthomet, Inc. · 1994
  • K930771Perfecta Total Hip System Coated Cocr Femoral StemOrthomet, Inc. · 1994

https://510kreport.com/device/K931678 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931678: Orthomet LHMC Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931678

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