Cleared Traditional

ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES (K001733) - FDA 510(k) Clearance

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

K001733 · Zimmer, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2000
Decision
13d
Days
Class 2
Risk

K001733 is an FDA 510(k) clearance for the ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8.... Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 20, 2000 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K001733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2000
Decision Date June 20, 2000
Days to Decision 13 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
109d faster than avg
Panel avg: 122d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K001733.
ONCOLOGY SALVAGE SYSTEM
K002757 · Biomet, Inc. · Nov 2000
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
K002106 · Biomet, Inc. · Jul 2000
TI-MAX PROTRUSIO CAGE
K001376 · Biomet, Inc. · Jul 2000
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
K001335 · Exactech, Inc. · May 2000
PAR 5 ACETABULAR COMPONENT
K000254 · Biomet, Inc. · Feb 2000
MALLORY/HEAD SMOOTH FEMORAL COMPONENT
K994007 · Biomet, Inc. · Feb 2000