Cleared Traditional

Taperloc® Complete Hip Stems (K200196) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200196 · Biomet Orthopedics · Orthopedic device
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Dec 2020
Decision
316d
Days
Class 2
Risk

K200196 is an FDA 510(k) clearance for the Taperloc® Complete Hip Stems. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Biomet Orthopedics (Warsaw, US). The FDA issued a Cleared decision on December 8, 2020 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Biomet Orthopedics devices

Submission Details

510(k) Number K200196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2020
Decision Date December 08, 2020
Days to Decision 316 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
194d slower than avg
Panel avg: 122d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 291
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K200196.
EcoFit® Hip System
K203420 · Implantcast GmbH · Feb 2021
M-Vizion Femoral Revision System Extension
K201471 · Medacta International S.A. · Jan 2021
Quadra-P
K202730 · Medacta International S.A. · Dec 2020
SMS Cementless Stem
K203041 · Medacta International S.A. · Dec 2020
DePuy Corail AMT Hip Prosthesis
K203167 · DePuy Orthopaedics, Inc. · Nov 2020
SMS Cementless Stem
K201673 · Medacta International S.A. · Sep 2020