Cleared Traditional

K953689 - WAGNER REVISION STEM (MODIFICATION)

K953689 is an FDA 510(k) clearance for WAGNER REVISION STEM (MODIFICATION), manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K953689 · Intermedics Orthopedics · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 1995
Decision
121d
Days
Class 2
Risk

K953689 is an FDA 510(k) clearance for the WAGNER REVISION STEM (MODIFICATION). Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 - K953689

510(k) Number K953689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1995
Decision Date November 29, 1995
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K953689.
BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM
K955350 · Biomet, Inc. · Feb 1996
FINE GRAIN CAST COBALT CHROMIUM HIP STEMS
K953925 · Biomet, Inc. · Jan 1996
CLS ACETABULAR COMPONENT (MODIFICATION)
K953688 · Intermedics Orthopedics · Nov 1995
ZIRCONIA CERAMIC FEMORAL HEAD
K944689 · Wrightmedicaltechnologyinc · Oct 1995
BUCHALTER FAUSER FEMORAL COMPONENTS
K952686 · Biomet, Inc. · Sep 1995
STELKAST ALL POLYETHYLENE ACETABULAR CUP
K953169 · Stelkast Company · Aug 1995