Cleared Traditional

K080979 - STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT

K080979 is an FDA 510(k) clearance for STAGEONE SELECT CEMENT SPACER MOLDS FOR..., manufactured by Biomet Manufacturing Corp. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K080979 · Biomet Manufacturing Corp · Orthopedic device
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Oct 2008
Decision
207d
Days
Class 2
Risk

K080979 is an FDA 510(k) clearance for the STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on October 31, 2008 after a review of 207 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet Manufacturing Corp devices

FDA 510(k) Submission Details - K080979

510(k) Number K080979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2008
Decision Date October 31, 2008
Days to Decision 207 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 122d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWY Device Classification - Class 2, Special Controls

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 92
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K080979.
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