Cleared Traditional

K982447 - PLUS BIPOLAR PROSTHESIS COCRMO

K982447 is an FDA 510(k) clearance for PLUS BIPOLAR PROSTHESIS COCRMO, manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K982447 · Plus Orthopedics · Orthopedic device
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Nov 1998
Decision
133d
Days
Class 2
Risk

K982447 is an FDA 510(k) clearance for the PLUS BIPOLAR PROSTHESIS COCRMO. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Plus Orthopedics (San Diego, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 133 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 Plus Orthopedics devices

FDA 510(k) Submission Details - K982447

510(k) Number K982447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1998
Decision Date November 25, 1998
Days to Decision 133 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 122d · This submission: 133d
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 K982447.
M2A 32MM TAPER SYSTEM
K003363 · Biomet, Inc. · Dec 2000
TRI-POLAR SYSTEM
K991990 · Biomet, Inc. · Sep 1999
G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
K982812 · Johnson & Johnson Professionals, Inc. · Dec 1998
ODC B2 BIPOLAR CUP
K982389 · Ortho Development Corp. · Oct 1998
J-FX BIPOLAR HEAD
K980801 · Johnson & Johnson Professionals, Inc. · May 1998
IMPLEX BIPOLAR HIP SYSTEM
K970447 · Implex Corp. · Apr 1997