Cleared Traditional

K894148 - MOD. FEMORAL COMP. NON-BEADED & BASIC A...

K894148 is the FDA 510(k) clearance for MOD. FEMORAL COMP. NON-BEADED & BASIC A... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K894148 · Howmedica Corp. · Orthopedic device
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Sep 1989
Decision
83d
Days
Class 2
Risk

K894148 is an FDA 510(k) clearance for the MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 83 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 Howmedica Corp. devices

Submission Details

510(k) Number K894148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1989
Decision Date September 05, 1989
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 435
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K894148.
FREEMAN MODULAR HIP STEM RIDGED VERSION
K890498 · Orthopedic Systems, Inc. · Oct 1989
MODIFIED GEMINI ACETABULAR CUP
K894298 · Depuy, Inc. · Sep 1989
MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL
K894149 · Howmedica Corp. · Sep 1989
UNIVERSAL CEMENTED CUP
K894249 · Orthopedic Systems, Inc. · Aug 1989
APR COLLARED REVISION FEMORAL COMPONENT
K885192 · Intermedics Orthopedics · Jun 1989
EXETER II TOTAL HIP SYSTEM
K891454 · Howmedica Corp. · Jun 1989