Cleared Traditional

K920161 - BIOMET NTS FEMORAL COMPONENTS

K920161 is an FDA 510(k) clearance for BIOMET NTS FEMORAL COMPONENTS, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K920161 · Biomet, Inc. · Orthopedic device
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Apr 1992
Decision
90d
Days
Class 2
Risk

K920161 is an FDA 510(k) clearance for the BIOMET NTS 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 April 13, 1992 after a review of 90 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K920161

510(k) Number K920161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1992
Decision Date April 13, 1992
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K920161.
PRECISION STRATA TOTAL HIP STEM
K921383 · Howmedica Corp. · Jun 1992
DEPUY TOTAL HIP BALLS - ION IMPLANTATION
K920286 · Depuy, Inc. · Apr 1992
OSTEONICS MICROSURFACED CDH HIP STEM
K920250 · Stryker Corp. · Apr 1992
S-ROM LF FEMORAL HEAD
K920317 · Joint Medical Products Corp. · Mar 1992
DRG CEMETED STEM
K920003 · Intermedics Orthopedics · Mar 1992
PERFECTA PDA TOTAL HIP SYSTEM
K915795 · Orthomet, Inc. · Mar 1992