Cleared Traditional

K132539 - RING-LOK MODULAR BIPOLAR SYSTEM

K132539 is an FDA 510(k) clearance for RING-LOK MODULAR BIPOLAR SYSTEM, manufactured by Implants International, Ltd.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K132539 · Implants International, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
178d
Days
Class 2
Risk

K132539 is an FDA 510(k) clearance for the RING-LOK MODULAR BIPOLAR SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Implants International, Ltd. (Hlliard, US). The FDA issued a Cleared decision on February 7, 2014 after a review of 178 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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.

FDA 510(k) Submission Details - K132539

510(k) Number K132539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2013
Decision Date February 07, 2014
Days to Decision 178 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
56d slower than avg
Panel avg: 122d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWY Device Classification - Class 2, Special Controls

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 96
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K132539.
Fitmore® Hip Stem
K170072 · Zimmer GmbH · Feb 2017
U2 Bipolar Implant and 22mm Femoral Head
K152439 · United Orthopedic Corporation · Apr 2016
Klassic BiPolar System
K143113 · Total Joint Orthopedics · Jan 2015
RENOVIS BIPOLAR HIP SYSTEM
K131354 · Renovis Surgical Technologies, LLC · Sep 2013
DEPUY CORAIL AMT HIP PROSTHESIS
K123991 · Depuy France S.A.S. · Sep 2013
TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT
K121509 · Tgm Medical, Inc. · Nov 2012
K132539 · RING-LOK MODULAR BIPOLAR SYSTEM
Download PDF FDA Summary Implants Internationa…