Cleared Traditional

K955739 - MODULAR ACETABULAR SHELL II

K955739 is an FDA 510(k) clearance for MODULAR ACETABULAR SHELL II, 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 100-day FDA review.

K955739 · Intermedics Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
100d
Days
Class 2
Risk

K955739 is an FDA 510(k) clearance for the MODULAR ACETABULAR SHELL II. 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 March 27, 1996 after a review of 100 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K955739

510(k) Number K955739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1995
Decision Date March 27, 1996
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
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 K955739.
FENNING FEMORAL COMPONENT
K960303 · Biomet, Inc. · Jun 1996
HEMISPHERE ACETABULAR CUP
K960660 · Ortho Development Corp. · May 1996
22 MM COCR HEAD & POLYETHLENE LINER
K960180 · Stelkast Company · May 1996
DEPUY POROCOAT HPS II HIP PROSTHESIS W/ARTICUL-EZE TAPER
K960172 · Depuy, Inc. · Mar 1996
HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT
K955871 · Howmedica Corp. · Mar 1996
ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP
K955511 · Joint Medical Products Corp. · Feb 1996