Cleared Traditional

K163585 - Responsive Orthopedics Total Hip Arthroplasty System

K163585 is an FDA 510(k) clearance for Responsive Orthopedics Total Hip Arthro..., manufactured by Responsive Orthopedics, LLC. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K163585 · Responsive Orthopedics, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
164d
Days
Class 2
Risk

K163585 is an FDA 510(k) clearance for the Responsive Orthopedics Total Hip Arthroplasty System. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Responsive Orthopedics, LLC (Columbia City, US). The FDA issued a Cleared decision on June 2, 2017 after a review of 164 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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.

FDA 510(k) Submission Details - K163585

510(k) Number K163585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2016
Decision Date June 02, 2017
Days to Decision 164 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
42d slower than avg
Panel avg: 122d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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

Medtronic, Inc.
Kathy Remsen

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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 528
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K163585.
OMNI Anseris Hip Stem
K171156 · Omnilife Science · Aug 2017
MiniMAX
K170845 · Medacta International S.A. · Aug 2017
Corin MetaFix Hip Stem
K162942 · Corin U.S.A. Limited · Jun 2017
AMIStem-H Proximal Coating
K161635 · Medacta International S.A. · Mar 2017
LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated
K161840 · Waldemar Link GmbH & Co. KG · Mar 2017
Revision Femoral Stem
K161226 · Lima Corporate S.P.A. · Feb 2017