Cleared Traditional

K833991 - BIPOLAR HIP DEVICE

K833991 is an FDA 510(k) clearance for BIPOLAR HIP DEVICE, manufactured by Zimmer. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K833991 · Zimmer · Orthopedic device
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Jan 1984
Decision
70d
Days
Class 2
Risk

K833991 is an FDA 510(k) clearance for the BIPOLAR HIP DEVICE. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Zimmer (Warsaw, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K833991

510(k) Number K833991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1983
Decision Date January 30, 1984
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWY Device Classification - Class 2, Special Controls

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 Consultant

Zimmer, Inc.
Max Sherman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 98
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K833991.
KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD
K853795 · Kirschner Medical Corp. · Nov 1985
HASTINGS BIPOLAR ENDOPROSTHESIS
K842344 · Johnson & Johnson Professionals, Inc. · Sep 1984
BDH BIPOLAR FEMORAL COMPONENT A3
K833404 · Carbomedics, Inc. · Mar 1984
BIOMET BIPOLAR PROSTHESIS
K833175 · Biomet, Inc. · Dec 1983
SPECTRON CONVERSION ENDOPROSTHESIS CUP
K823726 · Richard'S Medical Equip., Inc. · Mar 1983
101 UNIVERSAL ENDOPROSTHESIS
K823482 · Intermedics Orthopedics · Feb 1983
K833991 · BIPOLAR HIP DEVICE
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