Cleared Traditional

K051223 - HIPSTAR FEMORAL STEM

K051223 is an FDA 510(k) clearance for HIPSTAR FEMORAL STEM, manufactured by Stryker Orthopaedics. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K051223 · Stryker Orthopaedics · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2006
Decision
363d
Days
Class 2
Risk

K051223 is an FDA 510(k) clearance for the HIPSTAR FEMORAL STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on May 10, 2006 after a review of 363 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 Stryker Orthopaedics devices

FDA 510(k) Submission Details - K051223

510(k) Number K051223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2005
Decision Date May 10, 2006
Days to Decision 363 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
241d slower than avg
Panel avg: 122d · This submission: 363d
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 451
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K051223.
PATIENT MATCHED HIP STEM
K053246 · Smith & Nephew, Inc. · Jul 2006
36MM BIOLOX DELTA CERAMIC HEADS
K061312 · Biomet, Inc. · Jun 2006
EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
K060918 · Aesculap, Inc. · May 2006
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
K060577 · Ortho Development Corp. · Apr 2006
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS
K053587 · Ortho Development Corp. · Mar 2006
MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
K060107 · Exactech, Inc. · Feb 2006