Cleared Traditional

K964178 - PRESS-FIT HIP STEM

K964178 is an FDA 510(k) clearance for PRESS-FIT HIP STEM, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K964178 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
199d
Days
Class 2
Risk

K964178 is an FDA 510(k) clearance for the PRESS-FIT HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on May 5, 1997 after a review of 199 days - an extended review cycle.

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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K964178

510(k) Number K964178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1996
Decision Date May 05, 1997
Days to Decision 199 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
77d slower than avg
Panel avg: 122d · This submission: 199d
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 57
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K964178.
HOWMEDICA OSTEONICS FEMORAL HEADS
K993601 · Howmedica Osteonics Corp. · Nov 1999
OSTEONICS EXTENDED FEMORAL BEARING HEAD
K982936 · Osteonics Corp. · Oct 1998
PLUS-FIT ACETABULAR CUP
K973077 · Plus Orthopedics · Nov 1997
PERFECTA REVISION HIP SYSTEM
K955553 · Wrightmedicaltechnologyinc · Oct 1996
DELTA HIP PROSTHESIS
K961378 · Zimmer, Inc. · Oct 1996
PRESS-FIT FLARED SHELL
K960633 · Encore Orthopedics, Inc. · Oct 1996