Cleared Traditional

K923734 - TOTAL HIP PROTHESIS FEMORAL COMPONENT

K923734 is an FDA 510(k) clearance for TOTAL HIP PROTHESIS FEMORAL COMPONENT, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K923734 · Intermedics Orthopedics · Orthopedic device
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Jun 1993
Decision
322d
Days
Class 2
Risk

K923734 is an FDA 510(k) clearance for the TOTAL HIP PROTHESIS FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on June 14, 1993 after a review of 322 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K923734

510(k) Number K923734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1992
Decision Date June 14, 1993
Days to Decision 322 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 122d · This submission: 322d
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 K923734.
SL-PLUS & SLR-PLUS STEMS W/BIOLOX CERAMIC HEADS
K930963 · Encore Orthopedics, Inc. · Jan 1994
MULLER STRAIGHT STEM FEMORAL PROSTHESIS
K923808 · Techmedica, Inc. · Jul 1993
WALKER HIP PROSTHESIS
K915222 · Zimmer, Inc. · Jun 1993
INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD
K920968 · Dow Corning Wright · May 1993
OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD
K925695 · Osteonics Corp. · Apr 1993
CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION
K925512 · Dow Corning Wright · Feb 1993