Cleared Traditional

K963101 - B-P HEMISPHERICAL ACETABULAR COMPONENT

K963101 is an FDA 510(k) clearance for B-P HEMISPHERICAL ACETABULAR COMPONENT, manufactured by Endotec, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K963101 · Endotec, Inc. · Orthopedic device
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Feb 1997
Decision
187d
Days
Class 2
Risk

K963101 is an FDA 510(k) clearance for the B-P HEMISPHERICAL ACETABULAR COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Endotec, Inc. (South Orange, US). The FDA issued a Cleared decision on February 12, 1997 after a review of 187 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 Endotec, Inc. devices

FDA 510(k) Submission Details - K963101

510(k) Number K963101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1996
Decision Date February 12, 1997
Days to Decision 187 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 122d · This submission: 187d
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 Orthopedic devices follow this clearance model.

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

All 492
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K963101.
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
K965164 · Howmedica Corp. · Mar 1997
OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION)
K964924 · Osteoimplant Technology, Inc. · Mar 1997
VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
K964769 · Zimmer, Inc. · Feb 1997
GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON
K963509 · Smith & Nephew Richards, Inc. · Jan 1997
OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)
K963946 · Osteonics Corp. · Jan 1997
METAL BACKED ACETABULAR COMPONENT
K963998 · Encore Orthopedics, Inc. · Jan 1997