Cleared Traditional

IOI BIPOLAR PROSTHESIS (K873815) - FDA 510(k) Clearance

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

K873815 · Intermedics Orthopedics · Orthopedic device
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Oct 1987
Decision
37d
Days
Class 2
Risk

K873815 is an FDA 510(k) clearance for the IOI BIPOLAR PROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on October 28, 1987 after a review of 37 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 Intermedics Orthopedics devices

Submission Details

510(k) Number K873815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1987
Decision Date October 28, 1987
Days to Decision 37 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 122d · This submission: 37d
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 K873815.
VS22 HIP PROSTHESIS
K896266 · 3M Company · Nov 1989
P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT
K893872 · Johnson & Johnson Professionals, Inc. · Sep 1989
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