Cleared Traditional

K021661 - RINGLOC CONSTRAINED LINERS

K021661 is an FDA 510(k) clearance for RINGLOC CONSTRAINED LINERS, manufactured by Biomet Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code KWZ cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K021661 · Biomet Orthopedics, Inc. · Orthopedic device
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Oct 2002
Decision
158d
Days
Class 2
Risk

K021661 is an FDA 510(k) clearance for the RINGLOC CONSTRAINED LINERS. Classified as Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (product code KWZ), Class II - Special Controls.

Submitted by Biomet Orthopedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 25, 2002 after a review of 158 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3310 - 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 Orthopedics, Inc. devices

FDA 510(k) Submission Details - K021661

510(k) Number K021661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2002
Decision Date October 25, 2002
Days to Decision 158 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
36d slower than avg
Panel avg: 122d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWZ Device Classification - Class 2, Special Controls

Product Code KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3310
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 - KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

All 32
Devices cleared under the same product code (KWZ) and FDA review panel - the closest regulatory comparables to K021661.
FREEDOM CONSTRAINED LINERS
K030047 · Biomet, Inc. · Jan 2003
TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES
K021826 · Zimmer, Inc. · Dec 2002
REFLECTION CONSTRAINED LINER
K021803 · Smith & Nephew, Inc. · Dec 2002
RINGLOC CONSTRAINED LINERS II
K021728 · Biomet, Inc. · Oct 2002
RINGLOC CONSTRAINED LINER
K950202 · Biomet, Inc. · May 1995
OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT
K890197 · Osteonics Corp. · Apr 1989