Cleared Traditional

K963109 - HERITAGE HIP SYSTEM

K963109 is an FDA 510(k) clearance for HERITAGE HIP SYSTEM, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K963109 · Zimmer, Inc. · Orthopedic device
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Jan 1997
Decision
150d
Days
Class 2
Risk

K963109 is an FDA 510(k) clearance for the HERITAGE HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 9, 1997 after a review of 150 days - an extended review cycle.

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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K963109

510(k) Number K963109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1996
Decision Date January 09, 1997
Days to Decision 150 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
28d slower than avg
Panel avg: 122d · This submission: 150d
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 K963109.
HEDROCEL ACETABULAR RESTRICTOR
K962468 · Implex Corp. · Feb 1997
OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP
K963671 · Osteonics Corp. · Feb 1997
MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA
K964350 · Intermedics Orthopedics · Jan 1997
PERFECTA PLASMA SPRAY HIP STEM
K964218 · Wrightmedicaltechnologyinc · Jan 1997
EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD
K964262 · Exactech, Inc. · Dec 1996
REVISION HIP SYSTEM
K963486 · Smith & Nephew Richards, Inc. · Nov 1996