Cleared Traditional

RINGLOC + HYBRID ACETABULAR SYSTEM (K093235) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K093235 · Biomet, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2010
Decision
197d
Days
Class 3
Risk

K093235 is an FDA 510(k) clearance for the RINGLOC + HYBRID ACETABULAR SYSTEM. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 30, 2010 after a review of 197 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3330 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 Biomet, Inc. devices

Submission Details

510(k) Number K093235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2009
Decision Date April 30, 2010
Days to Decision 197 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
75d slower than avg
Panel avg: 122d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3330
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

All 57
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K093235.
CONSERVE BIO FOAM SHELL
K110029 · Wrightmedicaltechnologyinc · Apr 2011
ANTERIOR APPROACH HIP SURGERY INSTRUMENTS
K102565 · Wrightmedicaltechnologyinc · Dec 2010
TAPERLOC COMPLETE
K101086 · Biomet, Inc. · Sep 2010
BIOMET MODULAR FEMORAL REVISION SYSTEM
K090757 · Biomet, Inc. · Sep 2009
PROFEMUR HIP SYSTEM MODULAR NECKS
K091423 · Wrightmedicaltechnologyinc · Aug 2009
DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER
K082924 · Wrightmedicaltechnologyinc · Mar 2009