Cleared Traditional

K981238 - BIPOLAR FEMORAL HEAD

K981238 is an FDA 510(k) clearance for BIPOLAR FEMORAL HEAD, manufactured by Whiteside Biomechanics, Inc.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K981238 · Whiteside Biomechanics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
140d
Days
Class 2
Risk

K981238 is an FDA 510(k) clearance for the BIPOLAR FEMORAL HEAD. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Whiteside Biomechanics, Inc. (Creve Coeur, US). The FDA issued a Cleared decision on August 21, 1998 after a review of 140 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 Whiteside Biomechanics, Inc. devices

FDA 510(k) Submission Details - K981238

510(k) Number K981238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1998
Decision Date August 21, 1998
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
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 86
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K981238.
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
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
ARTOS, DIPLOS SYSTEM
K970284 · Turnkey Intergration USA, Inc. · Apr 1997