Cleared Traditional

K153057 - FitRite™ Total Hip Arthroplasty System

K153057 is an FDA 510(k) clearance for FitRite Total Hip Arthroplasty System, manufactured by Excera Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K153057 · Excera Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
246d
Days
Class 2
Risk

K153057 is an FDA 510(k) clearance for the FitRite™ Total Hip Arthroplasty System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Excera Orthopedics, Inc. (Newton, US). The FDA issued a Cleared decision on June 23, 2016 after a review of 246 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 - K153057

510(k) Number K153057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2015
Decision Date June 23, 2016
Days to Decision 246 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
124d slower than avg
Panel avg: 122d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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

Orchid Design
KELLEN HILLS

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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 528
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K153057.
Libertas Hip Replacement System
K180973 · Maxx Orthopedics, Inc. · Sep 2018
MALUC™ Total Hip Arthroplasty System
K162125 · Surgtech, Inc. · May 2017
REDAPT Anteverted Cemented Liner
K160923 · Smith & Nephew, Inc. · Nov 2016
Corin TaperFit Hip Stem
K153725 · Corin U.S.A. Limited · Mar 2016
Alpine Cemented Hip System
K153216 · Ortho Development Corporation · Feb 2016
OSS/Arcos IM Total Femur Rod
K152621 · Biomet, Inc. · Oct 2015