Cleared Traditional

K953578 - PROTEK ACETABULAR ROOF REINFORCEMENT RING

K953578 is an FDA 510(k) clearance for PROTEK ACETABULAR ROOF REINFORCEMENT RING, 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 90-day FDA review.

K953578 · Intermedics Orthopedics · Orthopedic device
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Oct 1995
Decision
90d
Days
Class 2
Risk

K953578 is an FDA 510(k) clearance for the PROTEK ACETABULAR ROOF REINFORCEMENT RING. 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 30, 1995 after a review of 90 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 - K953578

510(k) Number K953578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1995
Decision Date October 30, 1995
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K953578.
REALITY LONG STEM HIP SYSTEM
K954219 · Kinamed, Inc. · Dec 1995
ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)
K951139 · Wrightmedicaltechnologyinc · Nov 1995
NEXUS II FEMORAL COMPONENT
K954262 · Wrightmedicaltechnologyinc · Nov 1995
SLT 28MM XXL FEMORAL HEAD
K953025 · Wrightmedicaltechnologyinc · Sep 1995
FORGED CEMENTED STEM
K952191 · Encore Orthopedics, Inc. · Jul 1995
FOUNDATION POROUS STEM
K935263 · Encore Orthopedics, Inc. · Jul 1995