Cleared Traditional

K960588 - WAGNER REVISION STEM

K960588 is an FDA 510(k) clearance for WAGNER REVISION STEM, 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 175-day FDA review.

K960588 · Intermedics Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
175d
Days
Class 2
Risk

K960588 is an FDA 510(k) clearance for the WAGNER REVISION STEM. 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 August 5, 1996 after a review of 175 days - an extended review cycle.

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 - K960588

510(k) Number K960588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1996
Decision Date August 05, 1996
Days to Decision 175 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
53d slower than avg
Panel avg: 122d · This submission: 175d
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 K960588.
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
K955877 · Zimmer, Inc. · Oct 1996
P.F.C. CERAMIC HIP HEAD
K962248 · Johnson & Johnson Professionals, Inc. · Aug 1996
ZWEYMUELLER SL FEMORAL HIP STEM
K962101 · Intermedics Orthopedics · Aug 1996
APR OVERSIZED HIP STEM
K961921 · Intermedics Orthopedics · Aug 1996
NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM
K961727 · Intermedics Orthopedics · Jul 1996
APR FULLY TEXTURED HIP STEM
K961589 · Intermedics Orthopedics · Jul 1996