Cleared Traditional

K051569 - RINGLOC BI-POLAR ACETABULAR COMPONENT

K051569 is an FDA 510(k) clearance for RINGLOC BI-POLAR ACETABULAR COMPONENT, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 107-day FDA review.

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

FDA 510(k) Submission Details - K051569

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.

JDI Device Classification - Class 2, Special Controls

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 516
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K051569.
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER
K052639 · Biomet Manufacturing, Inc. · May 2006
SYSTEM 12 X3 ACETABULAR INSERTS
K052748 · Howmedica Osteonics Corp. · Dec 2005
ANTHOLOGY HIP STEM
K052792 · Smith & Nephew, Inc. · Oct 2005
ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS
K050637 · Ortho Development Corp. · Sep 2005
LEGEND ALL-POLY CUP
K051407 · Ortho Development Corp. · Sep 2005
TRABECULAR METAL REVISION SHELL LINERS
K051516 · Zimmer, Inc. · Jul 2005