Cleared Special

K122798 - INTEGRIP ACETABULAR SHELL

K122798 is the FDA 510(k) clearance for INTEGRIP ACETABULAR SHELL by Exactech, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Special 510(k) pathway after a 29-day FDA review.

K122798 · Exactech, Inc. · Orthopedic device
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Oct 2012
Decision
29d
Days
Class 2
Risk

K122798 is an FDA 510(k) clearance for the INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on October 11, 2012 after a review of 29 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 Exactech, Inc. devices

Submission Details

510(k) Number K122798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2012
Decision Date October 11, 2012
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K122798.
REVELATION POROUS COATED HIP STEM, SIZE 8
K122636 · Encore Medical, L.P. · Nov 2012
SMITH & NEPHEW SMF HIP STEM
K123012 · Smith & Nephew, Inc. · Oct 2012
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS
K123019 · Zimmer, Inc. · Oct 2012
FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH
K122504 · United Orthopedic Corporation · Oct 2012
BENCOX II STEM, BENCOX METAL HEAD
K122099 · Corentec Co., Ltd. · Oct 2012
NOVATION LPI PRIME FEMORAL STEM
K121684 · Exactech, Inc. · Oct 2012