Cleared Traditional

BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS (K912712) - FDA 510(k) Clearance

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

K912712 · Biomet, Inc. · Orthopedic device
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Dec 1991
Decision
184d
Days
Class 2
Risk

K912712 is an FDA 510(k) clearance for the BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS. 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 December 20, 1991 after a review of 184 days - an extended review 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: 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 Biomet, Inc. devices

Submission Details

510(k) Number K912712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1991
Decision Date December 20, 1991
Days to Decision 184 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 122d · This submission: 184d
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 K912712.
BIOMET NTS FEMORAL COMPONENTS
K920161 · Biomet, Inc. · Apr 1992
SOLUTION SYSTEM CUP
K915216 · Depuy, Inc. · Feb 1992
PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP
K911802 · Biomet, Inc. · Jan 1992
PT II DISTAL CEMENT SPACER
K914406 · Osteonics Corp. · Dec 1991
OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES
K913812 · Osteonics Corp. · Nov 1991
MODULAR CALCAR REPLACEMENT
K913649 · Zimmer, Inc. · Nov 1991