Cleared Traditional

K970300 - NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI

K970300 is an FDA 510(k) clearance for NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K970300 · Intermedics Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
160d
Days
Class 2
Risk

K970300 is an FDA 510(k) clearance for the NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 160 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 - K970300

510(k) Number K970300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1997
Decision Date July 03, 1997
Days to Decision 160 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 122d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 446
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K970300.
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IMPLEX A-240 HEP ACETABULAR CUP SYSTEM
K964509 · Implex Corp. · Jun 1997
TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS
K964650 · Depuy, Inc. · Jun 1997
INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES
K970705 · Sulzer Orthopedics, Inc. · May 1997