Cleared Traditional

K950202 - RINGLOC CONSTRAINED LINER

K950202 is an FDA 510(k) clearance for RINGLOC CONSTRAINED LINER, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code KWZ cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K950202 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
117d
Days
Class 2
Risk

K950202 is an FDA 510(k) clearance for the RINGLOC CONSTRAINED LINER. Classified as Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (product code KWZ), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 117 days - within the typical 510(k) review window.

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, Inc. devices

FDA 510(k) Submission Details - K950202

510(k) Number K950202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1995
Decision Date May 15, 1995
Days to Decision 117 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
5d faster than avg
Panel avg: 122d · This submission: 117d
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 31
Devices cleared under the same product code (KWZ) and FDA review panel - the closest regulatory comparables to K950202.
REFLECTION CONSTRAINED LINER
K021803 · Smith & Nephew, Inc. · Dec 2002
RINGLOC CONSTRAINED LINERS
K021661 · Biomet Orthopedics, Inc. · Oct 2002
RINGLOC CONSTRAINED LINERS II
K021728 · Biomet, Inc. · Oct 2002
OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT
K890197 · Osteonics Corp. · Apr 1989
S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP
K870271 · Joint Medical Products Corp. · Apr 1987
HCL ACETABULAR COMPONENTS
K803192 · Osteonics Corp. · Jan 1981