Cleared Traditional

K161635 - AMIStem-H Proximal Coating

K161635 is an FDA 510(k) clearance for AMIStem-H Proximal Coating, manufactured by Medacta International S.A.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K161635 · Medacta International S.A. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2017
Decision
290d
Days
Class 2
Risk

K161635 is an FDA 510(k) clearance for the AMIStem-H Proximal Coating. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on March 31, 2017 after a review of 290 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medacta International S.A. devices

FDA 510(k) Submission Details - K161635

510(k) Number K161635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2016
Decision Date March 31, 2017
Days to Decision 290 days
Submission Type Traditional
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
168d slower than avg
Panel avg: 122d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

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 509
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K161635.
MiniMAX
K170845 · Medacta International S.A. · Aug 2017
Corin MetaFix Hip Stem
K162942 · Corin U.S.A. Limited · Jun 2017
Responsive Orthopedics Total Hip Arthroplasty System
K163585 · Responsive Orthopedics, LLC · Jun 2017
LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated
K161840 · Waldemar Link GmbH & Co. KG · Mar 2017
Revision Femoral Stem
K161226 · Lima Corporate S.P.A. · Feb 2017
Initia Total Hip System & BIOCERAM AZUL(R) HEAD
K160895 · Kyocera Medical Corporation · Nov 2016