Cleared Special

K193233 - Restoration® Modular Hip System

K193233 is an FDA 510(k) clearance for Restoration Modular Hip System, manufactured by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 184-day FDA review.

K193233 · Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
184d
Days
Class 2
Risk

K193233 is an FDA 510(k) clearance for the Restoration® Modular Hip System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) (Mahwah, US). The FDA issued a Cleared decision on May 27, 2020 after a review of 184 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K193233

510(k) Number K193233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2019
Decision Date May 27, 2020
Days to Decision 184 days
Submission Type Special
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
62d slower than avg
Panel avg: 122d · This submission: 184d
Pathway characteristics
Modification to existing cleared device.

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 564
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K193233.
DePuy PINNACLE Dual Mobility Liner
K200854 · Depuy Ireland UC · Sep 2020
Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head
K191708 · Signature Orthopaedics Pty, Ltd. · Aug 2020
Delta Multihole TT Pro Acetabular System
K200656 · Lima Corporate S.P.A. · Jul 2020
KeYi Total Hip System
K191826 · Beijing Keyi Medical Device Technology Co., Ltd. · May 2020
Precision Casting Solutions Total Hip System
K192450 · Precision Casting Solution, LLC · Dec 2019
Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
K190656 · Zimmer, Inc. · Dec 2019
K193233 · Restoration® Modular Hip System
Download PDF FDA Summary Howmedica Osteonics C…