Cleared Traditional

K922682 - AMERICANA HIP PROTHESIS

K922682 is an FDA 510(k) clearance for AMERICANA HIP PROTHESIS, manufactured by Osteo Technology, Inc.. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 285-day FDA review.

K922682 · Osteo Technology, Inc. · Orthopedic device
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Mar 1993
Decision
285d
Days
Class 2
Risk

K922682 is an FDA 510(k) clearance for the AMERICANA HIP PROTHESIS. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Osteo Technology, Inc. (Timonium, US). The FDA issued a Cleared decision on March 16, 1993 after a review of 285 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 Osteo Technology, Inc. devices

FDA 510(k) Submission Details - K922682

510(k) Number K922682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1992
Decision Date March 16, 1993
Days to Decision 285 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
163d slower than avg
Panel avg: 122d · This submission: 285d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDG Device Classification - Class 2, Special Controls

Product Code JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
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 - JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

All 46
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K922682.
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BRIDGE(TM) HIP SYSTEM
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STABILITY HIP STEM WITH POROCOAT
K915787 · Depuy, Inc. · Apr 1993
INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE
K911595 · Dow Corning Wright · Jul 1991
OPTI-FIX COLLARED FEMORAL COMPONENTS
K874868 · Richards Medical Co., Inc. · Jan 1988
PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K874575 · Dow Corning Wright · Jan 1988