Cleared Traditional

OSTEONICS 22MM, +10 NECK BEARING HEADS (K933359) - FDA 510(k) Clearance

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

K933359 · Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
241d
Days
Class 2
Risk

K933359 is an FDA 510(k) clearance for the OSTEONICS 22MM, +10 NECK BEARING HEADS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 241 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 K933359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1993
Decision Date March 07, 1994
Days to Decision 241 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
119d slower than avg
Panel avg: 122d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 24
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K933359.
LFIC OR FETTO HIP
K952776 · Zimmer, Inc. · Feb 1996
HOWMEDICA V40 22MM FEMORAL HEAD
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COBALT CHROME GEMINI
K934909 · Depuy, Inc. · Apr 1994
HOWMEDICA HNR SYSTEM
K903563 · Howmedica Corp. · Mar 1991
THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH
K905254 · Depuy, Inc. · Feb 1991
ACSYS SELFTAP ACETABULAR CUP PROSTHESIS
K900262 · 3M Company · Sep 1990