Cleared Special

K172456 - Bone Screws 6.5mm

K172456 is an FDA 510(k) clearance for Bone Screws 6.5mm, 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 143-day FDA review.

K172456 · Lima Corporate S.P.A. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
143d
Days
Class 2
Risk

K172456 is an FDA 510(k) clearance for the Bone Screws 6.5mm. 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 January 4, 2018 after a review of 143 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. 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 - K172456

510(k) Number K172456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2017
Decision Date January 04, 2018
Days to Decision 143 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
21d slower than avg
Panel avg: 122d · This submission: 143d
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 K172456.
Trinity PLUS Acetabular Shell
K172551 · Corin U.S.A. Limited · Jun 2018
Legend Acetabular Liners
K173951 · Ortho Development Corporation · May 2018
Mpact® 3D Metal™ Implants and Augments 3D Metal™
K171966 · Medacta International S.A. · Mar 2018
Birmingham Hip (BH) Dual Mobility Insert
K171934 · Smith & Nephew, Inc. · Nov 2017
Smith & Nephew, Inc. REDAPT Augments
K171073 · Smith & Nephew, Inc. · Nov 2017
UTS Stem
K172251 · United Orthopedic Corporation · Oct 2017
K172456 · Bone Screws 6.5mm
Download PDF FDA Summary Lima Corporate S.P.A.