Cleared Traditional

K082705 - BIOPRO BIPOLAR HEAD

K082705 is the FDA 510(k) clearance for BIOPRO BIPOLAR HEAD by Biopro, Inc.. It is a Class 2 Orthopedic device (product code KWY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K082705 · Biopro, Inc. · Orthopedic device
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Dec 2008
Decision
90d
Days
Class 2
Risk

K082705 is an FDA 510(k) clearance for the BIOPRO BIPOLAR HEAD, MODELS 18130-18152. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on December 15, 2008 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 Biopro, Inc. devices

Submission Details

510(k) Number K082705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2008
Decision Date December 15, 2008
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 74
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K082705.
BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP
K112019 · Corentec Co., Ltd. · Oct 2011
BIOPRO POLAR HEAD
K100761 · Biopro, Inc. · Dec 2010
MEDACTA BIPOLAR HEAD
K091967 · Medacta International S.A. · Mar 2010
STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
K080979 · Biomet Manufacturing Corp · Oct 2008
GLADIATOR BIPOLAR SYSTEM
K062693 · Wrightmedicaltechnologyinc · Sep 2006
AESCULAP BIPOLAR ACETABULAR CUP
K060707 · Aesculap, Inc. · May 2006