Cleared Traditional

K935913 - HOWMEDICA SENTRY S TOTAL HIP SYSTEM

K935913 is the FDA 510(k) clearance for HOWMEDICA SENTRY S TOTAL HIP SYSTEM by Howmedica, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 370-day FDA review.

K935913 · Howmedica, Inc. · Orthopedic device
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Dec 1994
Decision
370d
Days
Class 2
Risk

K935913 is an FDA 510(k) clearance for the HOWMEDICA SENTRY S TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Howmedica, Inc. (Rutherford, US). The FDA issued a Cleared decision on December 15, 1994 after a review of 370 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 Howmedica, Inc. devices

Submission Details

510(k) Number K935913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1993
Decision Date December 15, 1994
Days to Decision 370 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
248d slower than avg
Panel avg: 122d · This submission: 370d
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 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K935913.
CDH HIP STEM
K945096 · Howmedica Corp. · Jan 1995
HOWMEDICA ALUMINA FEMORAL HEAD
K945091 · Howmedica Corp. · Jan 1995
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
K944601 · Zimmer, Inc. · Jan 1995
APR II NON POROUS HIP STEM
K944209 · Intermedics Orthopedics · Dec 1994
ZIRCONIA CERAMIC FEMORAL HEAD
K935921 · Smith & Nephew Richards, Inc. · Nov 1994
MODULAR CERAMIC FEMORAL HEAD
K936256 · Stelkast Company · Nov 1994