Cleared Traditional

RINGLOC BI-POLAR ACETABULAR COMPONENT (K051569) - FDA 510(k) Clearance

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

K051569 · Biomet, Inc. · Orthopedic device
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Sep 2005
Decision
107d
Days
Class 2
Risk

K051569 is an FDA 510(k) clearance for the RINGLOC BI-POLAR ACETABULAR COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 29, 2005 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Biomet, Inc. devices

Submission Details

510(k) Number K051569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2005
Decision Date September 29, 2005
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K051569.
EXCIA TOTAL HIP SYSTEM LATERAL OFFSET
K061344 · Aesculap, Inc. · Aug 2006
SYSTEM 12 X3 ACETABULAR INSERTS
K052748 · Howmedica Osteonics Corp. · Dec 2005
ANTHOLOGY HIP STEM
K052792 · Smith & Nephew, Inc. · Oct 2005
TRABECULAR METAL REVISION SHELL LINERS
K051516 · Zimmer, Inc. · Jul 2005
TAPER 2 POROUS FEMORAL STEM
K050441 · Biomet, Inc. · Jun 2005
RESTORATION MODULAR SYSTEM
K051363 · Howmedica Osteonics Corp. · Jun 2005