Cleared Traditional

K844941 - CFE ACETABULAR CUP

K844941 is an FDA 510(k) clearance for CFE ACETABULAR CUP, 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 75-day FDA review.

K844941 · Biomet, Inc. · Orthopedic device
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Mar 1985
Decision
75d
Days
Class 2
Risk

K844941 is an FDA 510(k) clearance for the CFE ACETABULAR CUP. 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 March 5, 1985 after a review of 75 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

FDA 510(k) Submission Details - K844941

510(k) Number K844941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1984
Decision Date March 05, 1985
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
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 466
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K844941.
THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP
K852153 · Howmedica Corp. · Aug 1985
LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS
K852705 · Waldemar Link GmbH & Co. KG · Aug 1985
MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM
K844817 · Osteonics Corp. · Mar 1985
BROOKER ACETABULAR CUP
K845005 · Biomet, Inc. · Feb 1985
LORD SCREW RING ACETABULAR COMPONENT
K844028 · Howmedica Corp. · Feb 1985
HAP ACETABULAR CUP
K843190 · Depuy, Inc. · Nov 1984