Cleared Traditional

K171543 - Renovis Surgical Hip Replacement System

K171543 is an FDA 510(k) clearance for Renovis Surgical Hip Replacement System, manufactured by Renovis Surgical Technologies. The device is a Class 2 Orthopedic device with product code OQG cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K171543 · Renovis Surgical Technologies · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 2017
Decision
174d
Days
Class 2
Risk

K171543 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 (Redlands, US). The FDA issued a Cleared decision on November 16, 2017 after a review of 174 days - an extended review cycle.

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 devices

FDA 510(k) Submission Details - K171543

510(k) Number K171543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2017
Decision Date November 16, 2017
Days to Decision 174 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
52d slower than avg
Panel avg: 122d · This submission: 174d
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 K171543.
KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
K201660 · Kyocera Medical Technologies, Inc. · Jul 2020
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
K200328 · Kyocera Medical Technologies, Inc. · Mar 2020
FMP Extended Liners
K172651 · Encore Medical, L.P. · Dec 2017
Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly
K173104 · Total Joint Orthopedics, Inc. · Oct 2017
Renovis Surgical Hip Replacement System
K143647 · Renovis Surgical Technologies, Inc. · May 2015
X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED
K140130 · Encore Medical, L.P. · Nov 2014