Cleared Traditional

K093046 - ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES

K093046 is an FDA 510(k) clearance for ELIBRA UNI SOFT-TISSUE FORCE SENSOR, manufactured by Synvasive Technology, Inc.. The device is a Class 2 Orthopedic device with product code ONN cleared through the Traditional 510(k) pathway after a 538-day FDA review.

K093046 · Synvasive Technology, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K093046

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.

ONN Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ONN Intraoperative Orthopedic Joint Assessment Aid

All 17
Devices cleared under the same product code (ONN) and FDA review panel - the closest regulatory comparables to K093046.
ELIBRA SOFT-TISSUE FORCE SENSOR
K132104 · Kamm & Associates · Mar 2014
ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
K131767 · Orthosensor, Inc. · Nov 2013
ORTHOSENSOR KNEE BALANCER
K130380 · Orthosensor, Inc. · Jun 2013
ORTHOREX INTRA-OPERATIVE LOAD SENSOR
K090474 · Orthosensor, Inc. · Oct 2009
ELIBRA DYNAMIC KNEE BALANCER
K070108 · Synvasive Technology, Inc. · Apr 2007
K093046 · ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES
Download PDF FDA Summary Synvasive Technology,…