Cleared Traditional

K942330 - APR II FEMORAL COMPONENT (VARIOUS)

K942330 is an FDA 510(k) clearance for APR II FEMORAL COMPONENT (VARIOUS), 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 141-day FDA review.

K942330 · Intermedics Orthopedics · Orthopedic device
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Oct 1994
Decision
141d
Days
Class 2
Risk

K942330 is an FDA 510(k) clearance for the APR II FEMORAL COMPONENT (VARIOUS). 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 October 4, 1994 after a review of 141 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 - K942330

510(k) Number K942330 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 16, 1994
Decision Date October 04, 1994
Days to Decision 141 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
19d slower than avg
Panel avg: 122d · This submission: 141d
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 K942330.
MODULAR CERAMIC FEMORAL HEAD
K936256 · Stelkast Company · Nov 1994
ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)
K943586 · Biomet, Inc. · Oct 1994
SOLUTION BOWED FEMORAL HIP PROTSTHESIS
K933942 · Depuy, Inc. · Oct 1994
5/8 POROCOAT AML HIP POROCOAT POROUS COATING
K941847 · Depuy, Inc. · Jul 1994
SOLUTION HIP
K941942 · Depuy, Inc. · Jul 1994
STABILITY HIP STEM WITH POROCOAT
K934457 · Depuy, Inc. · Jul 1994