Cleared Traditional

AESCULAP BIPOLAR ACETABULAR CUP (K060707) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K060707 · Aesculap, Inc. · Orthopedic device
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May 2006
Decision
76d
Days
Class 2
Risk

K060707 is an FDA 510(k) clearance for the AESCULAP BIPOLAR ACETABULAR CUP. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on May 31, 2006 after a review of 76 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aesculap, Inc. devices

Submission Details

510(k) Number K060707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2006
Decision Date May 31, 2006
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 47
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K060707.
40-42mm BiPolar Head and 22mm Femoral Head
K163081 · Signature Orthopaedics Pty, Ltd. · Jan 2018
MEDACTA BIPOLAR HEAD
K091967 · Medacta International S.A. · Mar 2010
GLADIATOR BIPOLAR SYSTEM
K062693 · Wrightmedicaltechnologyinc · Sep 2006
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM
K052990 · Biomet, Inc. · Dec 2005
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
K023743 · Smith & Nephew, Inc. · Jan 2003
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
K013211 · Exactech, Inc. · Dec 2001