Cleared Traditional

OMNIFIT II HIP PROSTHESES: CEMENT FIXATION (K870235) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K870235.
ANATOMIC TOTAL HIP
K874229 · Zimmer, Inc. · Nov 1987
POROUS COATED ACETABULAR CUP
K873585 · Johnson & Johnson Professionals, Inc. · Oct 1987
HPS II CALCAR FEMORAL PROSTHESIS
K871857 · Depuy, Inc. · Jun 1987
MODIFIED PROFILE HIP PMMA CEMENT SPACER
K871510 · Depuy, Inc. · May 1987
STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP
K870699 · Depuy, Inc. · May 1987
MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS
K870216 · Osteonics Corp. · Mar 1987