Cleared Traditional

K940389 - S.T.E.P. UNI-KNEE

K940389 is an FDA 510(k) clearance for S.T.E.P. UNI-KNEE, manufactured by S.T.E.P. Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 358-day FDA review.

K940389 · S.T.E.P. Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
358d
Days
Class 2
Risk

K940389 is an FDA 510(k) clearance for the S.T.E.P. UNI-KNEE. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by S.T.E.P. Orthopaedics, Inc. (Waterford, US). The FDA issued a Cleared decision on January 19, 1995 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all S.T.E.P. Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K940389

510(k) Number K940389 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 26, 1994
Decision Date January 19, 1995
Days to Decision 358 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
236d slower than avg
Panel avg: 122d · This submission: 358d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRY Device Classification - Class 2, Special Controls

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 86
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K940389.
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K944538 · Depuy, Inc. · Sep 1995
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K933935 · Techmedica, Inc. · Oct 1994
OSTEONICS UNIX UNICOMPARTMENTAL
K923011 · Osteonics Corp. · Nov 1993
P.F.C. UNICONDYLAR KNEE SYSTEM
K910968 · Johnson & Johnson Orthopaedics, Inc. · Aug 1991