Cleared Traditional

K922863 - EUROSTEM HIP PROTHESIS SYSTEM

K922863 is an FDA 510(k) clearance for EUROSTEM HIP PROTHESIS SYSTEM, manufactured by Osteo Technology, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K922863 · Osteo Technology, Inc. · Orthopedic device
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Feb 1993
Decision
253d
Days
Class 2
Risk

K922863 is an FDA 510(k) clearance for the EUROSTEM HIP PROTHESIS SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Osteo Technology, Inc. (Timonium, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 253 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 Osteo Technology, Inc. devices

FDA 510(k) Submission Details - K922863

510(k) Number K922863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1992
Decision Date February 12, 1993
Days to Decision 253 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 122d · This submission: 253d
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 493
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K922863.
TECHMEDICA CAD/CAM CUSTOM HIP
K911058 · Techmedica, Inc. · Feb 1993
AUSTIN-MOORE TYPE HIP PROSTHESIS
K922860 · Osteo Technology, Inc. · Feb 1993
CHARNLEY TYPE HIP PROTHESIS
K922862 · Osteo Technology, Inc. · Feb 1993
MUELLER TYPE FEMORAL STEM
K922864 · Osteo Technology, Inc. · Feb 1993
OTI BONE PLUG
K922866 · Osteo Technology, Inc. · Feb 1993
UNIFIT FEMORAL STEM
K922871 · Osteo Technology, Inc. · Feb 1993