Cleared Traditional

FEMORAL HEMI-HIP PROSTHESIS (K862460) - FDA 510(k) Clearance

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

K862460 · Orthopaedic Device Corp. · Orthopedic device
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Oct 1986
Decision
98d
Days
Class 2
Risk

K862460 is an FDA 510(k) clearance for the FEMORAL HEMI-HIP PROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Orthopaedic Device Corp. (Paterson, US). The FDA issued a Cleared decision on October 6, 1986 after a review of 98 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 Orthopaedic Device Corp. devices

Submission Details

510(k) Number K862460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1986
Decision Date October 06, 1986
Days to Decision 98 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 122d · This submission: 98d
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 48
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K862460.
ZIMMER BEADED THREADED ACETABULAR CUP
K884658 · Zimmer, Inc. · Nov 1988
JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS
K873514 · Johnson & Johnson Professionals, Inc. · Sep 1987
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
HASTINGS BIPOLAR ENDOPROSTHESIS
K842344 · Johnson & Johnson Professionals, Inc. · Sep 1984