Cleared Traditional

K100151 - APEX HIP SYSTEM BIPOLAR HEAD

K100151 is an FDA 510(k) clearance for APEX HIP SYSTEM BIPOLAR HEAD, manufactured by Omnlife Science. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K100151 · Omnlife Science · Orthopedic device
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May 2010
Decision
129d
Days
Class 2
Risk

K100151 is an FDA 510(k) clearance for the APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 .... Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Omnlife Science (Raynham, US). The FDA issued a Cleared decision on May 28, 2010 after a review of 129 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 Omnlife Science devices

FDA 510(k) Submission Details - K100151

510(k) Number K100151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2010
Decision Date May 28, 2010
Days to Decision 129 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 122d · This submission: 129d
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 85
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K100151.
BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP
K112019 · Corentec Co., Ltd. · Oct 2011
BIOPRO POLAR HEAD
K100761 · Biopro, Inc. · Dec 2010
UNITED U2 BIPOLAR IMPLANT
K101670 · United Orthopedic Corp. · Oct 2010
MEDACTA BIPOLAR HEAD
K091967 · Medacta International S.A. · Mar 2010
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)
K082468 · Omni Life Science, Inc. · Feb 2009
BIOPRO BIPOLAR HEAD, MODELS 18130-18152
K082705 · Biopro, Inc. · Dec 2008