Cleared Special

K082844 - BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K082844 · Encore Medical, L.P. · Orthopedic device
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Nov 2008
Decision
60d
Days
Class 2
Risk

K082844 is an FDA 510(k) clearance for the BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET S.... Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on November 25, 2008 after a review of 60 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Encore Medical, L.P. devices

Submission Details

510(k) Number K082844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2008
Decision Date November 25, 2008
Days to Decision 60 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 528
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