Cleared Traditional

K061168 - PCA 36MM FEMORAL HEADS

K061168 is the FDA 510(k) clearance for PCA 36MM FEMORAL HEADS by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K061168 · Howmedica Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2006
Decision
82d
Days
Class 2
Risk

K061168 is an FDA 510(k) clearance for the PCA 36MM FEMORAL HEADS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on July 18, 2006 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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: 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K061168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2006
Decision Date July 18, 2006
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 444
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