Cleared Traditional

K810062 - BI-CENTRIC BI-POLAR ENDOPROSTHESIS

K810062 is the FDA 510(k) clearance for BI-CENTRIC BI-POLAR ENDOPROSTHESIS by Howmedica Corp.. It is a Class 2 Orthopedic device (product code KWY) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810062 · Howmedica Corp. · Orthopedic device
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Jan 1981
Decision
13d
Days
Class 2
Risk

K810062 is an FDA 510(k) clearance for the BI-CENTRIC BI-POLAR ENDOPROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1981 after a review of 13 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.

View all Howmedica Corp. devices

Submission Details

510(k) Number K810062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1981
Decision Date January 26, 1981
Days to Decision 13 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
109d faster than avg
Panel avg: 122d · This submission: 13d
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 73
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K810062.
SPECTRON CONVERSION ENDOPROSTHESIS CUP
K823726 · Richard'S Medical Equip., Inc. · Mar 1983
101 UNIVERSAL ENDOPROSTHESIS
K823482 · Intermedics Orthopedics · Feb 1983
SELF-CENTERING HIP
K812672 · Depuy, Inc. · Oct 1981
3M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM
K791823 · 3M Company · Oct 1979
ENDOPROSTHESIS SYSTEM, VARIO-HEAD
K781735 · Waldemar Link GmbH & Co. KG · Oct 1978