Cleared Traditional

K222760 - StageOne™ Select Hip Cement Spacer Molds

K222760 is an FDA 510(k) clearance for StageOne Select Hip Cement Spacer Molds, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code MBB cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K222760 · Biomet, Inc. · Orthopedic device
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Dec 2022
Decision
106d
Days
Class 2
Risk

K222760 is an FDA 510(k) clearance for the StageOne™ Select Hip Cement Spacer Molds. Classified as Bone Cement, Antibiotic (product code MBB), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 28, 2022 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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, Inc. devices

FDA 510(k) Submission Details - K222760

510(k) Number K222760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2022
Decision Date December 28, 2022
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBB Device Classification - Class 2, Special Controls

Product Code MBB Bone Cement, Antibiotic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - MBB Bone Cement, Antibiotic

All 18
Devices cleared under the same product code (MBB) and FDA review panel - the closest regulatory comparables to K222760.
SpaceFix Shoulder Spacer
K252443 · G21, S.R.L. · Sep 2025
GENTAFIX® (1, 3, 3MV)
K242216 · Teknimed Sas · Dec 2024
Hip Spacer Molds
K240856 · Osartis GmbH · Nov 2024
StageOne™ Shoulder Cement Spacer Molds
K221968 · Biomet, Inc. · Sep 2022
StageOne Knee Cement Spacer Molds
K213287 · Biomet, Inc. · Sep 2022
SpaceFlex Shoulder
K202338 · G21, S.R.L. · Feb 2021