Cleared Traditional

K862057 - KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHE...

K862057 is an FDA 510(k) clearance for KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHE..., manufactured by Kirschner Medical Corp.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K862057 · Kirschner Medical Corp. · Orthopedic device
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Jul 1986
Decision
42d
Days
Class 2
Risk

K862057 is an FDA 510(k) clearance for the KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on July 11, 1986 after a review of 42 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 Kirschner Medical Corp. devices

FDA 510(k) Submission Details - K862057

510(k) Number K862057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1986
Decision Date July 11, 1986
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
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 Peers - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 79
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K862057.
IOI BIPOLAR PROSTHESIS
K873815 · Intermedics Orthopedics · Oct 1987
JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS
K873514 · Johnson & Johnson Professionals, Inc. · Sep 1987
BI-ARTICULAR II HIP DEVICE
K872019 · Zimmer, Inc. · Jul 1987
SLR BIPOLAR HIP ENDOPROSTHESIS
K861566 · Dow Corning Wright · May 1986
HOWMEDICA BIPOLAR PROSTHESIS
K861105 · Howmedica Corp. · Apr 1986
HOWMEDICA BIPOLAR PROSTHESIS
K855231 · Howmedica Corp. · Feb 1986