Cleared Traditional

K945089 - SENTRY TOTAL HIP

K945089 is the FDA 510(k) clearance for SENTRY TOTAL HIP by Howmedica Corp.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K945089 · Howmedica Corp. · Orthopedic device
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Jan 1995
Decision
94d
Days
Class 2
Risk

K945089 is an FDA 510(k) clearance for the SENTRY TOTAL HIP. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on January 19, 1995 after a review of 94 days - within the typical 510(k) review window.

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 Howmedica Corp. devices

Submission Details

510(k) Number K945089 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 17, 1994
Decision Date January 19, 1995
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
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 419
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K945089.
HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS
K946026 · Howmedica, Inc. · Mar 1995
OSTEONICS RESTORATION MONOLITHIC HIP STEM
K943774 · Osteonics Corp. · Mar 1995
NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM
K945516 · Intermedics Orthopedics · Feb 1995
HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD
K945090 · Howmedica Corp. · Jan 1995
P.C.A.PRIMARY HIP- CEMENTLESS USE
K945092 · Howmedica Corp. · Jan 1995
P.C.A. E-SERIES HIP- CEMENTLESS USE
K945093 · Howmedica, Inc. · Jan 1995