Cleared Special

K181532 - Exactech Alteon Monobloc Revision Stem

K181532 is the FDA 510(k) clearance for Exactech Alteon Monobloc Revision Stem by Exactech, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Special 510(k) pathway after a 85-day FDA review.

K181532 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
85d
Days
Class 2
Risk

K181532 is an FDA 510(k) clearance for the Exactech Alteon Monobloc Revision Stem. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on September 4, 2018 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 K181532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2018
Decision Date September 04, 2018
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 433
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K181532.
MicroPort Orthopedics Total Hip Systems MR Labeling
K173898 · Microport Orthopedics Inc. (Mpo) · Sep 2018
Prime E-CLASS XLPE Liner
K181598 · Microport Orthopedics, Inc. · Sep 2018
Corin Optimized Positioning System (OPS) Femoral
K181061 · Corin USA · Sep 2018
b-ONE® Total Hip System
K173380 · B-One Ortho, Corp. · Aug 2018
EcoFit Vit E Acetabular System
K180263 · Implantcast GmbH · Jul 2018
BIOLOX delta Option and Extra-long Heads
K173776 · Microport Orthopedics, Inc. · Jul 2018