Cleared Traditional

K945783 - ORTHOMET TITANIUM HYBRID FEMORAL STEM

K945783 is an FDA 510(k) clearance for ORTHOMET TITANIUM HYBRID FEMORAL STEM, manufactured by Orthomet, Inc.. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K945783 · Orthomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
186d
Days
Class 2
Risk

K945783 is an FDA 510(k) clearance for the ORTHOMET TITANIUM HYBRID FEMORAL STEM. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 186 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 Orthomet, Inc. devices

FDA 510(k) Submission Details - K945783

510(k) Number K945783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1994
Decision Date May 30, 1995
Days to Decision 186 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
64d slower than avg
Panel avg: 122d · This submission: 186d
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 44
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K945783.
AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
K962002 · Exactech, Inc. · Aug 1996
LUBINUS SP II HIP SYSTEM
K953653 · Turnkey Intergration USA, Inc. · Nov 1995
HIP FRACTURE STEM FENESTRATION PLUG
K953067 · Howmedica Corp. · Aug 1995
PROFORM CEMENTED FEMORAL COMPONENT
K951083 · Stelkast Company · May 1995
INTEGRAL CO-CR FEMORAL COMPONENT
K942479 · Biomet, Inc. · Sep 1994
IMPACT CO-CR 1-PIECE FEMORAL COMPONENT
K942027 · Biomet, Inc. · Sep 1994