Cleared Traditional

K811718 - SURFACE REPLACEMENT HIP PROSTHESIS

K811718 is an FDA 510(k) clearance for SURFACE REPLACEMENT HIP PROSTHESIS, manufactured by Biomet, Inc.. The device is a Class 1 Ophthalmic device with product code KYB cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K811718 · Biomet, Inc. · Ophthalmic device
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Sep 1981
Decision
92d
Days
Class 1
Risk

K811718 is an FDA 510(k) clearance for the SURFACE REPLACEMENT HIP PROSTHESIS. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 18, 1981 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - the FDA ophthalmic device 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet, Inc. devices

FDA 510(k) Submission Details - K811718

510(k) Number K811718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1981
Decision Date September 18, 1981
Days to Decision 92 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 110d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

KYB Device Classification - Class 1, General Controls

Product Code KYB Lens, Guide, Intraocular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.