Cleared Special

K172456 - Bone Screws 6.5mm

K172456 is the FDA 510(k) clearance for Bone Screws 6.5mm by Lima Corporate S.P.A.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Special 510(k) pathway after a 143-day FDA review.

K172456 · Lima Corporate S.P.A. · Orthopedic device
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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.

View all Lima Corporate S.P.A. devices

Submission Details

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.

Device Classification

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 446
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