Cleared Traditional

K933203 - APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-P...

K933203 is an FDA 510(k) clearance for APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-P..., 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 292-day FDA review.

K933203 · Intermedics Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K933203

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
Combination Product No
PCCP Authorized No
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.

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 K933203.
EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT
K931617 · Exactech, Inc. · Jun 1994
SLT FEMORAL HEAD
K932222 · Dow Corning Wright · May 1994
KIRSCHNER ZIRCONIA FEMORAL HEAD
K934694 · Kirschner Medical Corp. · May 1994
KINAMED REALITY TOTAL HIP SYSTEM
K922247 · Kinamed, Inc. · Mar 1994
TECHMEDICA CONTINUUM HIP SYSTEM
K931929 · Techmedica, Inc. · Mar 1994
ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)
K925345 · Biomet, Inc. · Mar 1994