Cleared Traditional

K954854 - INTERMOORE FRACTURE HIP STEM

K954854 is an FDA 510(k) clearance for INTERMOORE FRACTURE HIP STEM, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K954854 · Intermedics Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
115d
Days
Class 2
Risk

K954854 is an FDA 510(k) clearance for the INTERMOORE FRACTURE HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on February 15, 1996 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 - K954854

510(k) Number K954854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1995
Decision Date February 15, 1996
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LWJ Device Classification - Class 2, Special Controls

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 71
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K954854.
PRESS-FIT FLARED SHELL
K960633 · Encore Orthopedics, Inc. · Oct 1996
INTERMOORE FRACTURE HIP STEM (MODIFY)
K963155 · Intermedics Orthopedics · Oct 1996
SRRS PRESSED FIT FEMORAL REVISION COMPONENT
K960908 · Stelkast Company · Aug 1996
LFIC OR FETTO HIP
K952776 · Zimmer, Inc. · Feb 1996
DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT
K953268 · Stelkast Company · Jan 1996
FOUNDATION TEXTURED STEM
K952297 · Encore Orthopedics, Inc. · Jul 1995