Cleared Traditional

K191622 - Delta Multihole TT Pro Acetabular System

K191622 is an FDA 510(k) clearance for Delta Multihole TT Pro Acetabular System, manufactured by Lima Corporate S.P.A.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K191622 · Lima Corporate S.P.A. · Orthopedic device
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Nov 2019
Decision
136d
Days
Class 2
Risk

K191622 is an FDA 510(k) clearance for the Delta Multihole TT Pro Acetabular System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Lima Corporate S.P.A. (Villanova Di San Daniele Del Friuli, IT). The FDA issued a Cleared decision on November 1, 2019 after a review of 136 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 Lima Corporate S.P.A. devices

FDA 510(k) Submission Details - K191622

510(k) Number K191622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2019
Decision Date November 01, 2019
Days to Decision 136 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
14d slower than avg
Panel avg: 122d · This submission: 136d
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 Consultant

Peoples & Associates Consulting, LLC
Stephen Peoples

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 - 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 K191622.
Pinnacle Duofix HA Acetabular Cup Prosthesis
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Conformis Hip System
K192198 · Conformis, Inc. · Nov 2019
Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head
K183457 · Zimmer, Inc. · Nov 2019
OR3O Dual Mobility System
K191002 · Smith & Nephew, Inc. · Oct 2019
REDAPT Blade Augments
K190847 · Smith & Nephew, Inc. · Oct 2019
Trident II Acetabular System
K191358 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Oct 2019