Cleared Traditional

K955877 - ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD

K955877 is an FDA 510(k) clearance for ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K955877 · Zimmer, Inc. · Orthopedic device
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Oct 1996
Decision
287d
Days
Class 2
Risk

K955877 is an FDA 510(k) clearance for the ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 8, 1996 after a review of 287 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K955877

510(k) Number K955877 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 26, 1995
Decision Date October 08, 1996
Days to Decision 287 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 122d · This submission: 287d
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 K955877.
NATURAL-HIP SYSTEM COCR STEM
K964357 · Intermedics Orthopedics · Jan 1997
DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM
K964704 · Depuy, Inc. · Jan 1997
BRIDGE LONG STEM FEMORAL COMPONENT
K964249 · Wrightmedicaltechnologyinc · Jan 1997
P.F.C. CERAMIC HIP HEAD
K962248 · Johnson & Johnson Professionals, Inc. · Aug 1996
ZWEYMUELLER SL FEMORAL HIP STEM
K962101 · Intermedics Orthopedics · Aug 1996
WAGNER REVISION STEM
K960588 · Intermedics Orthopedics · Aug 1996