Cleared Traditional

NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM (K945516) - FDA 510(k) Clearance

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

K945516 · Intermedics Orthopedics · Orthopedic device
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Feb 1995
Decision
97d
Days
Class 2
Risk

K945516 is an FDA 510(k) clearance for the NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT 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 February 14, 1995 after a review of 97 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

Submission Details

510(k) Number K945516 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 09, 1994
Decision Date February 14, 1995
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
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 K945516.
V40 ZIRCONIA FEMORAL HEADS
K952418 · Howmedica Corp. · Jul 1995
ZIRCONIA ARTICUL/EZE FEMORAL BALLS
K952088 · Depuy, Inc. · Jun 1995
OSTEONICS RESTORATION MONOLITHIC HIP STEM
K943774 · Osteonics Corp. · Mar 1995
SENTRY TOTAL HIP
K945089 · Howmedica Corp. · Jan 1995
HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD
K945090 · Howmedica Corp. · Jan 1995
P.C.A.PRIMARY HIP- CEMENTLESS USE
K945092 · Howmedica Corp. · Jan 1995