Cleared Traditional

K143647 - Renovis Surgical Hip Replacement System

K143647 is an FDA 510(k) clearance for Renovis Surgical Hip Replacement System, manufactured by Renovis Surgical Technologies, Inc.. The device is a Class 2 Orthopedic device with product code OQG cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K143647 · Renovis Surgical Technologies, Inc. · Orthopedic device
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May 2015
Decision
140d
Days
Class 2
Risk

K143647 is an FDA 510(k) clearance for the Renovis Surgical Hip Replacement System. Classified as Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented (product code OQG), Class II - Special Controls.

Submitted by Renovis Surgical Technologies, Inc. (Redlands, US). The FDA issued a Cleared decision on May 11, 2015 after a review of 140 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

FDA 510(k) Submission Details - K143647

510(k) Number K143647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2014
Decision Date May 11, 2015
Days to Decision 140 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OQG Device Classification - Class 2, Special Controls

Product Code OQG Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
Definition 1. Non-inflammatory Degenerative Joint Disease Including Osteoarthritis And Avascular Necrosis. 2. Rheumatoid Arthritis. 3. Correction Of Functional Deformity. 4. Treatment Of Non-union, Femoral Neck Fracture, And Trochanteric Fractures Of The Proximal Femur With Head Involvement, Unmanageable By Other Techniques. 5. Revision Procedures Where Other Treatment Or Devices Have Failed. Cemented And Uncemented Use.
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 Consultant

MEDIcept, Inc.
Sharyn Orton

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OQG Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented

All 19
Devices cleared under the same product code (OQG) and FDA review panel - the closest regulatory comparables to K143647.
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