Cleared Traditional

K913634 - APR II HIP SYSTEM

K913634 is an FDA 510(k) clearance for APR II 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 123-day FDA review.

K913634 · Intermedics Orthopedics · Orthopedic device
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Dec 1991
Decision
123d
Days
Class 2
Risk

K913634 is an FDA 510(k) clearance for the APR II 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 December 16, 1991 after a review of 123 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 - K913634

510(k) Number K913634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1991
Decision Date December 16, 1991
Days to Decision 123 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
1d slower than avg
Panel avg: 122d · This submission: 123d
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 K913634.
BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS
K912712 · Biomet, Inc. · Dec 1991
S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD
K913231 · Joint Medical Products Corp. · Dec 1991
PT II DISTAL CEMENT SPACER
K914406 · Osteonics Corp. · Dec 1991
INFINITY(TM) MICROTAPER HIP SYSTEM
K913874 · Dow Corning Wright · Nov 1991
OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES
K913812 · Osteonics Corp. · Nov 1991
MODULAR CALCAR REPLACEMENT
K913649 · Zimmer, Inc. · Nov 1991