Cleared Traditional

K213287 - StageOne Knee Cement Spacer Molds

K213287 is an FDA 510(k) clearance for StageOne Knee 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 336-day FDA review.

K213287 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
336d
Days
Class 2
Risk

K213287 is an FDA 510(k) clearance for the StageOne Knee 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 September 2, 2022 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K213287

510(k) Number K213287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2021
Decision Date September 02, 2022
Days to Decision 336 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
214d slower than avg
Panel avg: 122d · This submission: 336d
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 K213287.
Hip Spacer Molds
K240856 · Osartis GmbH · Nov 2024
StageOne™ Select Hip Cement Spacer Molds
K222760 · Biomet, Inc. · Dec 2022
StageOne™ Shoulder Cement Spacer Molds
K221968 · Biomet, Inc. · Sep 2022
SpaceFlex Shoulder
K202338 · G21, S.R.L. · Feb 2021
SpaceFlex Knee - 80mm Size
K201960 · G21, S.R.L. · Aug 2020
G21 SpaceFlex Hip
K192041 · G21, S.R.L. · Oct 2019