Cleared Traditional

PROTEK LOW PROFILE ACETABULAR CUP (K960025) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K960025.
COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT
K960278 · Zimmer, Inc. · Jul 1996
COLLARLESS POLISHED TAPER HIP PROSTHESIS
K960658 · Zimmer, Inc. · Jul 1996
DEPUY ENDURANCE CALCAR HIP PROSTHESIS
K961619 · Depuy, Inc. · Jul 1996
OSTEONICS OFFSET HIP STEMS
K954598 · Osteonics Corp. · Apr 1996
GAMMA SYSTEM
K955473 · Zimmer, Inc. · Feb 1996
ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT
K952859 · Johnson & Johnson Professionals, Inc. · Jan 1996