Cleared Special

K141395 - DELTA TT ACETABULAR SYSTEM

K141395 is an FDA 510(k) clearance for DELTA TT ACETABULAR SYSTEM, manufactured by Lima Corporate S.P.A.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 33-day FDA review.

K141395 · Lima Corporate S.P.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
33d
Days
Class 2
Risk

K141395 is an FDA 510(k) clearance for the DELTA TT 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. (Udine, IT). The FDA issued a Cleared decision on June 30, 2014 after a review of 33 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lima Corporate S.P.A. devices

FDA 510(k) Submission Details - K141395

510(k) Number K141395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2014
Decision Date June 30, 2014
Days to Decision 33 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
89d faster than avg
Panel avg: 122d · This submission: 33d
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 543
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K141395.
ALPINE HIP STEM
K141001 · Ortho Development · Jul 2014
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ENCOMPASS 10/12 HIP STEM
K132697 · Ortho Development Corp. · Jun 2014
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K141043 · Consensus Orthopedics, Inc. · May 2014
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K132312 · Renovis Surgical Technologies, LLC · Apr 2014