Cleared Traditional

HASTINGS BIPOLAR ENDOPROSTHESIS (K842344) - FDA 510(k) Clearance

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

K842344 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Sep 1984
Decision
90d
Days
Class 2
Risk

K842344 is an FDA 510(k) clearance for the HASTINGS BIPOLAR ENDOPROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on September 12, 1984 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 888.3390 - 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K842344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1984
Decision Date September 12, 1984
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 47
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K842344.
BI-ARTICULAR II HIP DEVICE
K872019 · Zimmer, Inc. · Jul 1987
HOWMEDICA BIPOLAR PROSTHESIS
K861105 · Howmedica Corp. · Apr 1986
HOWMEDICA BIPOLAR PROSTHESIS
K855231 · Howmedica Corp. · Feb 1986
BIOMET BIPOLAR PROSTHESIS
K833175 · Biomet, Inc. · Dec 1983
SELF-CENTERING HIP
K812672 · Depuy, Inc. · Oct 1981
BI-CENTRIC BI-POLAR ENDOPROSTHESIS
K810062 · Howmedica Corp. · Jan 1981