Cleared Traditional

K894051 - PREMIER-TOTAL HIP

K894051 is an FDA 510(k) clearance for PREMIER-TOTAL HIP, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K894051 · Intermedics Orthopedics · Orthopedic device
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Aug 1989
Decision
82d
Days
Class 2
Risk

K894051 is an FDA 510(k) clearance for the PREMIER-TOTAL HIP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on August 28, 1989 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 - K894051

510(k) Number K894051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1989
Decision Date August 28, 1989
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LWJ Device Classification - Class 2, Special Controls

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 57
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K894051.
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