Cleared Traditional

K040685 - Z - SERIES MODULAR TOTAL HIP SYSTEM PLA...

K040685 is an FDA 510(k) clearance for Z - SERIES MODULAR TOTAL HIP SYSTEM PLA..., manufactured by Osteoimplant Technology, Inc.. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K040685 · Osteoimplant Technology, Inc. · Orthopedic device
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Jan 2005
Decision
315d
Days
Class 2
Risk

K040685 is an FDA 510(k) clearance for the Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Osteoimplant Technology, Inc. (Hunt Valley, US). The FDA issued a Cleared decision on January 25, 2005 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Osteoimplant Technology, Inc. devices

FDA 510(k) Submission Details - K040685

510(k) Number K040685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2004
Decision Date January 25, 2005
Days to Decision 315 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 122d · This submission: 315d
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 66
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K040685.
BETACONE HIP PROSTHESIS SYSTEM
K051826 · Waldemar Link GmbH & Co. KG · Nov 2005
U2 ACETABULAR COMPONENT
K050262 · United Orthopedic Corp. · Aug 2005
EXCIA TOTAL HIP SYSTEM
K042344 · Aesculap, Inc. · Mar 2005
MODULAR PLUS HIP STEM
K032709 · Plus Orthopedics · Sep 2003
PROCLASS PRESS FIT HIP STEM
K032110 · Stelkast Company · Sep 2003
MODIFICATION TO MODULAR PLUS REVISION STEM
K030971 · Plus Orthopedics · Apr 2003