Cleared Traditional

APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP (K933203) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933203 · Intermedics Orthopedics · Orthopedic device
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Apr 1994
Decision
292d
Days
Class 2
Risk

K933203 is an FDA 510(k) clearance for the APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP. 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 April 19, 1994 after a review of 292 days - an extended review cycle.

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 Intermedics Orthopedics devices

Submission Details

510(k) Number K933203 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 01, 1993
Decision Date April 19, 1994
Days to Decision 292 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 122d · This submission: 292d
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 292
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K933203.
SOLUTION HIP
K941942 · Depuy, Inc. · Jul 1994
STABILITY HIP STEM WITH POROCOAT
K934457 · Depuy, Inc. · Jul 1994
EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT
K931617 · Exactech, Inc. · Jun 1994
ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)
K925345 · Biomet, Inc. · Mar 1994
ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM
K926395 · Depuy, Inc. · Mar 1994
OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM
K932519 · Osteonics Corp. · Mar 1994