Cleared Traditional

K982389 - ODC B2 BIPOLAR CUP

K982389 is an FDA 510(k) clearance for ODC B2 BIPOLAR CUP, manufactured by Ortho Development Corp.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K982389 · Ortho Development Corp. · Orthopedic device
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Oct 1998
Decision
90d
Days
Class 2
Risk

K982389 is an FDA 510(k) clearance for the ODC B2 BIPOLAR CUP. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on October 7, 1998 after a review of 90 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 Ortho Development Corp. devices

FDA 510(k) Submission Details - K982389

510(k) Number K982389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1998
Decision Date October 07, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
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 76
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K982389.
TRI-POLAR SYSTEM
K991990 · Biomet, Inc. · Sep 1999
G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
K982812 · Johnson & Johnson Professionals, Inc. · Dec 1998
PLUS BIPOLAR PROSTHESIS COCRMO
K982447 · Plus Orthopedics · Nov 1998
J-FX BIPOLAR HEAD
K980801 · Johnson & Johnson Professionals, Inc. · May 1998
IMPLEX BIPOLAR HIP SYSTEM
K970447 · Implex Corp. · Apr 1997
ADVANTAGE MAPF HIP FEMORAL COMPONENT
K960643 · Biomet, Inc. · Dec 1996