Cleared Traditional

K890450 - INTERMEDICS APR(TM) II FEMORAL COMPONENT

K890450 is an FDA 510(k) clearance for INTERMEDICS APR(TM) II FEMORAL COMPONENT, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code JDJ cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K890450 · Intermedics Orthopedics · Orthopedic device
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Aug 1989
Decision
191d
Days
Class 2
Risk

K890450 is an FDA 510(k) clearance for the INTERMEDICS APR(TM) II FEMORAL COMPONENT. Classified as Mesh, Surgical, Acetabular, Hip, Prosthesis (product code JDJ), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on August 9, 1989 after a review of 191 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K890450

510(k) Number K890450 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 30, 1989
Decision Date August 09, 1989
Days to Decision 191 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 122d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDJ Device Classification - Class 2, Special Controls

Product Code JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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.