Cleared Traditional

K961526 - PRESS-FIT POROUS SHELL

K961526 is an FDA 510(k) clearance for PRESS-FIT POROUS SHELL, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K961526 · Encore Orthopedics, Inc. · Orthopedic device
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Sep 1996
Decision
148d
Days
Class 2
Risk

K961526 is an FDA 510(k) clearance for the PRESS-FIT POROUS SHELL. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on September 17, 1996 after a review of 148 days - within the typical 510(k) review window.

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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K961526

510(k) Number K961526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date September 17, 1996
Days to Decision 148 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
26d slower than avg
Panel avg: 122d · This submission: 148d
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 446
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K961526.
NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED
K963266 · Intermedics Orthopedics · Oct 1996
DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)
K962923 · Depuy, Inc. · Oct 1996
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
K961186 · Depuy, Inc. · Sep 1996
S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)
K961939 · Johnson & Johnson Professionals, Inc. · Aug 1996
FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS
K955563 · Encore Orthopedics, Inc. · Aug 1996
FENNING FEMORAL COMPONENT
K960303 · Biomet, Inc. · Jun 1996