Cleared Traditional

K190904 - Conformis BeneFIT Hip System

K190904 is an FDA 510(k) clearance for Conformis BeneFIT Hip System, manufactured by Conformis, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K190904 · Conformis, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
142d
Days
Class 2
Risk

K190904 is an FDA 510(k) clearance for the Conformis BeneFIT Hip System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Conformis, Inc. (Billerica, US). The FDA issued a Cleared decision on August 28, 2019 after a review of 142 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 Conformis, Inc. devices

FDA 510(k) Submission Details - K190904

510(k) Number K190904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2019
Decision Date August 28, 2019
Days to Decision 142 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
20d slower than avg
Panel avg: 122d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

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 540
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K190904.
REDAPT Blade Augments
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Trident II Acetabular System
K191358 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Oct 2019
iNSitu Total Hip System
K192071 · Theken Companies, LLC · Aug 2019
iNSitu Total Hip System
K191936 · Thecken Companies, LLC · Aug 2019
Medtronic Total Hip Arthroplasty System
K183129 · Medtronic Advanced Energy · Jul 2019
MicroPort CoCr Femoral Heads
K190123 · Microport Orthopedics, Inc. · Jul 2019