Cleared Traditional

K183129 - Medtronic Total Hip Arthroplasty System

K183129 is an FDA 510(k) clearance for Medtronic Total Hip Arthroplasty System, manufactured by Medtronic Advanced Energy. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K183129 · Medtronic Advanced Energy · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2019
Decision
255d
Days
Class 2
Risk

K183129 is an FDA 510(k) clearance for the Medtronic Total Hip Arthroplasty System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Medtronic Advanced Energy (Portsmouth, US). The FDA issued a Cleared decision on July 26, 2019 after a review of 255 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 Medtronic Advanced Energy devices

FDA 510(k) Submission Details - K183129

510(k) Number K183129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2018
Decision Date July 26, 2019
Days to Decision 255 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
133d slower than avg
Panel avg: 122d · This submission: 255d
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 534
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K183129.
iNSitu Total Hip System
K192071 · Theken Companies, LLC · Aug 2019
Conformis BeneFIT Hip System
K190904 · Conformis, Inc. · Aug 2019
iNSitu Total Hip System
K191936 · Thecken Companies, LLC · Aug 2019
MicroPort CoCr Femoral Heads
K190123 · Microport Orthopedics, Inc. · Jul 2019
DJO Acetabular System
K190057 · Encore Medical, L.P. · Jun 2019
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling
K182678 · Zimmer, Inc. · May 2019