Cleared Traditional

K861105 - HOWMEDICA BIPOLAR PROSTHESIS

K861105 is the FDA 510(k) clearance for HOWMEDICA BIPOLAR PROSTHESIS by Howmedica Corp.. It is a Class 2 Orthopedic device (product code KWY) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K861105 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
21d
Days
Class 2
Risk

K861105 is an FDA 510(k) clearance for the HOWMEDICA BIPOLAR PROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on April 14, 1986 after a review of 21 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 K861105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1986
Decision Date April 14, 1986
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 K861105.
BI-ARTICULAR II HIP DEVICE
K872019 · Zimmer, Inc. · Jul 1987
KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD
K862057 · Kirschner Medical Corp. · Jul 1986
SLR BIPOLAR HIP ENDOPROSTHESIS
K861566 · Dow Corning Wright · May 1986
HOWMEDICA BIPOLAR PROSTHESIS
K855231 · Howmedica Corp. · Feb 1986
KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD
K853795 · Kirschner Medical Corp. · Nov 1985
HASTINGS BIPOLAR ENDOPROSTHESIS
K842344 · Johnson & Johnson Professionals, Inc. · Sep 1984