Cleared Traditional

K913060 - NATURAL POROUS HIP SYSTEM

K913060 is an FDA 510(k) clearance for NATURAL POROUS HIP SYSTEM, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K913060 · Intermedics Orthopedics · Orthopedic device
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Oct 1991
Decision
93d
Days
Class 2
Risk

K913060 is an FDA 510(k) clearance for the NATURAL POROUS HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on October 11, 1991 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 - K913060

510(k) Number K913060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1991
Decision Date October 11, 1991
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K913060.
OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES
K913812 · Osteonics Corp. · Nov 1991
MODULAR CALCAR REPLACEMENT
K913649 · Zimmer, Inc. · Nov 1991
HYBRID FIT TOTAL HIP SYSTEM
K913246 · Kirschner Medical Corp. · Oct 1991
APR II NON-POROUS HIP STEM
K913208 · Intermedics Orthopedics · Oct 1991
MODULAR HIP SYSTEM
K912593 · Smith & Nephew Richards, Inc. · Oct 1991
APR COLLAR SPACER
K912916 · Intermedics Orthopedics · Sep 1991