Cleared Traditional

K963266 - NATURAL HIP SYSTEM POROUS STEM - COLLARLESS

K963266 is an FDA 510(k) clearance for NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K963266 · Intermedics Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
56d
Days
Class 2
Risk

K963266 is an FDA 510(k) clearance for the NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on October 15, 1996 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intermedics Orthopedics devices

FDA 510(k) Submission Details - K963266

510(k) Number K963266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1996
Decision Date October 15, 1996
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 K963266.
METAL BACKED ACETABULAR COMPONENT
K963998 · Encore Orthopedics, Inc. · Jan 1997
METAL ACETABULAR COMPONENT
K964227 · Encore Orthopedics, Inc. · Jan 1997
APEX HOLE ELIMINATOR PS
K963309 · Depuy, Inc. · Nov 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
PRESS-FIT POROUS SHELL
K961526 · Encore Orthopedics, Inc. · Sep 1996