Cleared Traditional

K870235 - OMNIFIT II HIP PROSTHESES: CEMENT FIXATION

K870235 is an FDA 510(k) clearance for OMNIFIT II HIP PROSTHESES: CEMENT FIXATION, manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K870235 · Osteonics Corp. · Orthopedic device
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May 1987
Decision
128d
Days
Class 2
Risk

K870235 is an FDA 510(k) clearance for the OMNIFIT II HIP PROSTHESES: CEMENT FIXATION. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on May 29, 1987 after a review of 128 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 Osteonics Corp. devices

FDA 510(k) Submission Details - K870235

510(k) Number K870235 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 21, 1987
Decision Date May 29, 1987
Days to Decision 128 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 122d · This submission: 128d
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 516
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K870235.
MURRAY/WELCH TOTAL HIP SYSTEM
K871402 · Kirschner Medical Corp. · Jul 1987
WAGNER REVISIONAL FEMORAL HIP PROSTHESIS
K871347 · Protek, Inc. · Jul 1987
HPS II CALCAR FEMORAL PROSTHESIS
K871857 · Depuy, Inc. · Jun 1987
MODIFIED PROFILE HIP PMMA CEMENT SPACER
K871510 · Depuy, Inc. · May 1987
KIRSCHNER MODULAR HIP SYSTEM
K871401 · Kirschner Medical Corp. · May 1987
HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE)
K870128 · Richards Medical Co., Inc. · May 1987