Cleared Traditional

K141676 - RENOVIS SURGICAL POROUS ACETABULAR CUP ...

K141676 is the FDA 510(k) clearance for RENOVIS SURGICAL POROUS ACETABULAR CUP ... by Renovis Surgical Technologies, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K141676 · Renovis Surgical Technologies, Inc. · Orthopedic device
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Nov 2014
Decision
134d
Days
Class 2
Risk

K141676 is an FDA 510(k) clearance for the RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Renovis Surgical Technologies, Inc. (Ashland, US). The FDA issued a Cleared decision on November 4, 2014 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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. Standard predicate reliance. 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 Renovis Surgical Technologies, Inc. devices

Submission Details

510(k) Number K141676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2014
Decision Date November 04, 2014
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 447
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