Cleared Traditional

K960025 - PROTEK LOW PROFILE ACETABULAR CUP

K960025 is an FDA 510(k) clearance for PROTEK LOW PROFILE ACETABULAR CUP, 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 157-day FDA review.

K960025 · Intermedics Orthopedics · Orthopedic device
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Jun 1996
Decision
157d
Days
Class 2
Risk

K960025 is an FDA 510(k) clearance for the PROTEK LOW PROFILE ACETABULAR CUP. 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 June 7, 1996 after a review of 157 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K960025

510(k) Number K960025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1996
Decision Date June 07, 1996
Days to Decision 157 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
35d slower than avg
Panel avg: 122d · This submission: 157d
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 K960025.
NATURAL HIP SYSTEM
K960258 · Intermedics Orthopedics · Jul 1996
DEPUY ENDURANCE CALCAR HIP PROSTHESIS
K961619 · Depuy, Inc. · Jul 1996
FOUNDATION 9MM FORGED CEMENTED STEM
K961890 · Encore Orthopedics, Inc. · Jun 1996
BURCH/SCHNEIDER REINFORCEMENT CAGE
K960678 · Intermedics Orthopedics · May 1996
MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)
K960626 · Intermedics Orthopedics · Apr 1996
OSTEONICS OFFSET HIP STEMS
K954598 · Osteonics Corp. · Apr 1996