Cleared Traditional

K944209 - APR II NON POROUS HIP STEM

K944209 is an FDA 510(k) clearance for APR II NON POROUS HIP STEM, 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 102-day FDA review.

K944209 · Intermedics Orthopedics · Orthopedic device
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Dec 1994
Decision
102d
Days
Class 2
Risk

K944209 is an FDA 510(k) clearance for the APR II NON POROUS HIP STEM. 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 December 9, 1994 after a review of 102 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K944209

510(k) Number K944209 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 29, 1994
Decision Date December 09, 1994
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
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 K944209.
HOWMEDICA ALUMINA FEMORAL HEAD
K945091 · Howmedica Corp. · Jan 1995
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
K944601 · Zimmer, Inc. · Jan 1995
HOWMEDICA SENTRY S TOTAL HIP SYSTEM
K935913 · Howmedica, Inc. · Dec 1994
ZIRCONIA CERAMIC FEMORAL HEAD
K935921 · Smith & Nephew Richards, Inc. · Nov 1994
MODULAR CERAMIC FEMORAL HEAD
K936256 · Stelkast Company · Nov 1994
ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)
K943586 · Biomet, Inc. · Oct 1994