Cleared Traditional

K962268 - CHROME COBALT BALL HEAD

K962268 is an FDA 510(k) clearance for CHROME COBALT BALL HEAD, manufactured by Artos Medical Products GmbH. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K962268 · Artos Medical Products GmbH · Orthopedic device
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Oct 1996
Decision
132d
Days
Class 2
Risk

K962268 is an FDA 510(k) clearance for the CHROME COBALT BALL HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Artos Medical Products GmbH (Indianapolis, US). The FDA issued a Cleared decision on October 23, 1996 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Artos Medical Products GmbH devices

FDA 510(k) Submission Details - K962268

510(k) Number K962268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1996
Decision Date October 23, 1996
Days to Decision 132 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 122d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LWJ Device Classification - Class 2, Special Controls

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 71
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K962268.
PRESS-FIT HIP STEM
K964178 · Encore Orthopedics, Inc. · May 1997
PERFECTA REVISION HIP SYSTEM
K955553 · Wrightmedicaltechnologyinc · Oct 1996
SC, CEMENTLESS HIP SYSTEM
K962034 · Artos Medical Products GmbH · Oct 1996
DELTA HIP PROSTHESIS
K961378 · Zimmer, Inc. · Oct 1996
PRESS-FIT FLARED SHELL
K960633 · Encore Orthopedics, Inc. · Oct 1996
INTERMOORE FRACTURE HIP STEM (MODIFY)
K963155 · Intermedics Orthopedics · Oct 1996