Cleared Traditional

CLS STEM (MODIFICATION) (K953690) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953690 · Intermedics Orthopedics · Orthopedic device
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Jun 1996
Decision
312d
Days
Class 2
Risk

K953690 is an FDA 510(k) clearance for the CLS 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 June 7, 1996 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Intermedics Orthopedics devices

Submission Details

510(k) Number K953690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1995
Decision Date June 07, 1996
Days to Decision 312 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 122d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 292
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K953690.
BRIDGE LONG STEM FEMORAL COMPONENT
K964249 · Wrightmedicaltechnologyinc · Jan 1997
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
K955877 · Zimmer, Inc. · Oct 1996
P.F.C. CERAMIC HIP HEAD
K962248 · Johnson & Johnson Professionals, Inc. · Aug 1996
BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM
K955350 · Biomet, Inc. · Feb 1996
FINE GRAIN CAST COBALT CHROMIUM HIP STEMS
K953925 · Biomet, Inc. · Jan 1996
ZIRCONIA CERAMIC FEMORAL HEAD
K944689 · Wrightmedicaltechnologyinc · Oct 1995