Cleared Traditional

K926201 - OSTEONICS MICROSUTERED FEMORAL COMPONENTES

K926201 is an FDA 510(k) clearance for OSTEONICS MICROSUTERED FEMORAL COMPONENTES, manufactured by Osteonics Corp.. The device is a Class 2 General Hospital device with product code LPH cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K926201 · Osteonics Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K926201

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.

LPH Device Classification - Class 2, Special Controls

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 543
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
HIP JOINT PROTHESIS
K921400 · Smith & Nephew Richards, Inc. · Apr 1993
POLY-DIAL INSERTS
K924492 · Joint Medical Products Corp. · Nov 1992
BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM
K921639 · Zimmer, Inc. · Jul 1992