Cleared Traditional

K905254 - THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH

K905254 is an FDA 510(k) clearance for THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL..., manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K905254 · Depuy, Inc. · Orthopedic device
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Feb 1991
Decision
95d
Days
Class 2
Risk

K905254 is an FDA 510(k) clearance for the THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 26, 1991 after a review of 95 days - within the typical 510(k) review window.

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 Depuy, Inc. devices

FDA 510(k) Submission Details - K905254

510(k) Number K905254 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 23, 1990
Decision Date February 26, 1991
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LWJ Device Classification - Class 2, Special Controls

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 73
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