Cleared Traditional

K961589 - APR FULLY TEXTURED HIP STEM

K961589 is an FDA 510(k) clearance for APR FULLY TEXTURED 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 76-day FDA review.

K961589 · Intermedics Orthopedics · Orthopedic device
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Jul 1996
Decision
76d
Days
Class 2
Risk

K961589 is an FDA 510(k) clearance for the APR FULLY TEXTURED 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 July 9, 1996 after a review of 76 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intermedics Orthopedics devices

FDA 510(k) Submission Details - K961589

510(k) Number K961589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1996
Decision Date July 09, 1996
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 K961589.
WAGNER REVISION STEM
K960588 · Intermedics Orthopedics · Aug 1996
APR OVERSIZED HIP STEM
K961921 · Intermedics Orthopedics · Aug 1996
NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM
K961727 · Intermedics Orthopedics · Jul 1996
CLS STEM (MODIFICATION)
K953690 · Intermedics Orthopedics · Jun 1996
IMPLEX CERAMIC HEAD
K955117 · Implex Corp. · Apr 1996
BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM
K955350 · Biomet, Inc. · Feb 1996