Cleared Traditional

K931678 - ORTHOMET LHMC FEMORAL STEM (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931678 · Orthomet, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
556d
Days
Class 2
Risk

K931678 is an FDA 510(k) clearance for the ORTHOMET LHMC FEMORAL STEM. Classified as Monitor, Eye Movement, Diagnostic (product code HMC), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 14, 1994 after a review of 556 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1510 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Orthomet, Inc. devices

Submission Details

510(k) Number K931678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1993
Decision Date October 14, 1994
Days to Decision 556 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
446d slower than avg
Panel avg: 110d · This submission: 556d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HMC Monitor, Eye Movement, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.