Cleared Traditional

BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER (K011455) - FDA 510(k) Clearance

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

K011455 · Biomet, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2001
Decision
68d
Days
Class 2
Risk

K011455 is an FDA 510(k) clearance for the BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 18, 2001 after a review of 68 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 Biomet, Inc. devices

Submission Details

510(k) Number K011455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2001
Decision Date July 18, 2001
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
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 K011455.
MODIFICATION TO DEPUY C-STEM SYSTEM
K013350 · DePuy Orthopaedics, Inc. · Nov 2001
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
K012493 · Exactech, Inc. · Aug 2001
COLOR BUFFED (CB) DDH FEMORAL STEM
K012019 · Biomet, Inc. · Jul 2001
TRIDENT ALL POLY CUP
K012026 · Howmedica Osteonics Corp. · Jul 2001
EXCEL FRACTURE CEMENTED HIP STEM
K011367 · DePuy Orthopaedics, Inc. · Jun 2001
EXETER HIP SYSTEM WITH V40 TAPER
K011623 · Howmedica Osteonics Corp. · Jun 2001