Cleared Traditional

K911802 - PMI (PATIENT MATCHED IMPLANTS) HIP FEMO...

K911802 is an FDA 510(k) clearance for PMI (PATIENT MATCHED IMPLANTS) HIP FEMO..., 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 254-day FDA review.

K911802 · Biomet, Inc. · Orthopedic device
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Jan 1992
Decision
254d
Days
Class 2
Risk

K911802 is an FDA 510(k) clearance for the PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP. 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 January 2, 1992 after a review of 254 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

FDA 510(k) Submission Details - K911802

510(k) Number K911802 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 23, 1991
Decision Date January 02, 1992
Days to Decision 254 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 122d · This submission: 254d
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 K911802.
DRG CEMETED STEM
K920003 · Intermedics Orthopedics · Mar 1992
PERFECTA PDA TOTAL HIP SYSTEM
K915795 · Orthomet, Inc. · Mar 1992
SOLUTION SYSTEM CUP
K915216 · Depuy, Inc. · Feb 1992
BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS
K912712 · Biomet, Inc. · Dec 1991
S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD
K913231 · Joint Medical Products Corp. · Dec 1991
PT II DISTAL CEMENT SPACER
K914406 · Osteonics Corp. · Dec 1991