Cleared Traditional

K944689 - ZIRCONIA CERAMIC FEMORAL HEAD

K944689 is an FDA 510(k) clearance for ZIRCONIA CERAMIC FEMORAL HEAD, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K944689 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
393d
Days
Class 2
Risk

K944689 is an FDA 510(k) clearance for the 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 Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on October 20, 1995 after a review of 393 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K944689

510(k) Number K944689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1994
Decision Date October 20, 1995
Days to Decision 393 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
271d slower than avg
Panel avg: 122d · This submission: 393d
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 511
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K944689.
CLS ACETABULAR COMPONENT (MODIFICATION)
K953688 · Intermedics Orthopedics · Nov 1995
WAGNER REVISION STEM (MODIFICATION)
K953689 · Intermedics Orthopedics · Nov 1995
CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5
K953792 · U.S. Medical Products, Inc. · Nov 1995
BUCHALTER FAUSER FEMORAL COMPONENTS
K952686 · Biomet, Inc. · Sep 1995
STELKAST ALL POLYETHYLENE ACETABULAR CUP
K953169 · Stelkast Company · Aug 1995
V40 ZIRCONIA FEMORAL HEADS
K952418 · Howmedica Corp. · Jul 1995