Cleared Traditional

K922645 - LSF ANATOMIC CEMENTED HIP

K922645 is an FDA 510(k) clearance for LSF ANATOMIC CEMENTED HIP, 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 218-day FDA review.

K922645 · Osteo Technology, Inc. · Orthopedic device
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Jan 1993
Decision
218d
Days
Class 2
Risk

K922645 is an FDA 510(k) clearance for the LSF ANATOMIC CEMENTED HIP. 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 January 7, 1993 after a review of 218 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 - K922645

510(k) Number K922645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1992
Decision Date January 07, 1993
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
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 K922645.
THE UNIVERSAL BONE CEMENT RESISTOR
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DEPUY HIP PROSTHESIS
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ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS
K924115 · Johnson & Johnson Orthopaedics, Inc. · Nov 1992
C-FIT CEMENTED HIP STEM
K923898 · Turnkey Intergration USA, Inc. · Nov 1992