Cleared Traditional

K093046 - ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES (FDA 510(k) Clearance)

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

K093046 · Synvasive Technology, Inc. · Orthopedic device
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Mar 2011
Decision
538d
Days
Class 2
Risk

K093046 is an FDA 510(k) clearance for the ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES. Classified as Intraoperative Orthopedic Joint Assessment Aid (product code ONN), Class II - Special Controls.

Submitted by Synvasive Technology, Inc. (Naples, US). The FDA issued a Cleared decision on March 22, 2011 after a review of 538 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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: 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 Orthopedic submissions.

View all Synvasive Technology, Inc. devices

Submission Details

510(k) Number K093046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2009
Decision Date March 22, 2011
Days to Decision 538 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
416d slower than avg
Panel avg: 122d · This submission: 538d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONN Intraoperative Orthopedic Joint Assessment Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Measurement And Interpretation Of Orthopedic Joint Information.
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.