Cleared Traditional

K994126 - MODULAR-PLUS REVISION STEM

K994126 is an FDA 510(k) clearance for MODULAR-PLUS REVISION STEM, manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K994126 · Plus Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
149d
Days
Class 2
Risk

K994126 is an FDA 510(k) clearance for the MODULAR-PLUS REVISION STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Plus Orthopedics (San Diego, US). The FDA issued a Cleared decision on May 4, 2000 after a review of 149 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 Plus Orthopedics devices

FDA 510(k) Submission Details - K994126

510(k) Number K994126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1999
Decision Date May 04, 2000
Days to Decision 149 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
27d slower than avg
Panel avg: 122d · This submission: 149d
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 K994126.
THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ
K001471 · Implex Corp. · Aug 2000
MODIFICATION TO PROVIDENT HIP SYSTEM
K001745 · Stelkast Company · Jul 2000
SL-PLUS AND SLR-PLUS STEMS
K001942 · Plus Orthopedics · Jul 2000
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