Cleared Traditional

K945516 - NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEM...

K945516 is an FDA 510(k) clearance for NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEM..., 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 97-day FDA review.

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

FDA 510(k) Submission Details - K945516

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
Combination Product No
PCCP Authorized No
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.

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 K945516.
ZIRCONIA ARTICUL/EZE FEMORAL BALLS
K952088 · Depuy, Inc. · Jun 1995
HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS
K946026 · Howmedica, Inc. · Mar 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