Cleared Traditional

OSTEONICS MICROSUTERED FEMORAL COMPONENTES (K926201) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K926201 · Osteonics Corp. · General Hospital
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Jun 1993
Decision
195d
Days
Class 2
Risk

K926201 is an FDA 510(k) clearance for the OSTEONICS MICROSUTERED FEMORAL COMPONENTES. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 195 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 888.3358 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteonics Corp. devices

Submission Details

510(k) Number K926201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1992
Decision Date June 22, 1993
Days to Decision 195 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 129d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 General Hospital devices follow this clearance model.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 324
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K926201.
EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR
K921114 · Exactech, Inc. · Oct 1993
INFINITY POROUS-COATED TROCHANTERIC MODULE
K922159 · Wrightmedicaltechnologyinc · Oct 1993
ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS
K926107 · Biomet, Inc. · Jul 1993
BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM
K921639 · Zimmer, Inc. · Jul 1992
TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS
K862702 · Depuy, Inc. · Jul 1986
POROUS COATED HIP FEMORAL PROSTHESIS
K862326 · Johnson & Johnson Professionals, Inc. · Jul 1986