Cleared Traditional

K950998 - MODUILAR UNIPOLAR

K950998 is an FDA 510(k) clearance for MODUILAR UNIPOLAR, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code KXA cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K950998 · Intermedics Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
41d
Days
Class 2
Risk

K950998 is an FDA 510(k) clearance for the MODUILAR UNIPOLAR. Classified as Prosthesis, Hip, Femoral, Resurfacing (product code KXA), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on April 13, 1995 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3400 - 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 - K950998

510(k) Number K950998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1995
Decision Date April 13, 1995
Days to Decision 41 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
81d faster than avg
Panel avg: 122d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXA Device Classification - Class 2, Special Controls

Product Code KXA Prosthesis, Hip, Femoral, Resurfacing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3400
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 - KXA Prosthesis, Hip, Femoral, Resurfacing

All 17
Devices cleared under the same product code (KXA) and FDA review panel - the closest regulatory comparables to K950998.
CEMENTED FEMORAL HEAD RESURFING DEVICE
K021799 · Biomet Orthopedics, Inc. · Jun 2002
CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS
K994153 · Corin USA · Feb 2000
NELSON RESURFACING HEAD
K983452 · Biomet, Inc. · Dec 1998
ORTHOMET RESURFACING FEMORAL COMPONENT
K944752 · Orthomet, Inc. · Dec 1994
BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT
K894604 · Biopro, Inc. · Nov 1989
BIPOLAR HIP SYSTEM
K892398 · Orthomet, Inc. · May 1989