Cleared Traditional

K182099 - Delta TT Pro

K182099 is an FDA 510(k) clearance for Delta TT Pro, 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 145-day FDA review.

K182099 · Lima Corporate S.P.A. · Orthopedic device
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Dec 2018
Decision
145d
Days
Class 2
Risk

K182099 is an FDA 510(k) clearance for the Delta TT Pro. 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 December 26, 2018 after a review of 145 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 - K182099

510(k) Number K182099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2018
Decision Date December 26, 2018
Days to Decision 145 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
23d slower than avg
Panel avg: 122d · This submission: 145d
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 541
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K182099.
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Alteon Acetabular Cup System
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Provident II Hip Stem
K190276 · Stelkast, Inc. · Mar 2019
REDAPT Modular Acetabular Shell
K182109 · Smith & Nephew, Inc. · Nov 2018
REDAPT Porous Acetabular Shell
K181366 · Smith & Nephew, Inc. · Sep 2018
Latitud Hip Replacement System
K172857 · Meril Healthcare Pvt. , Ltd. · Jul 2018