Cleared Traditional

K240856 - Hip Spacer Molds

Also marketed or referenced as:
Knee Spacer Molds Shoulder Spacer Molds

K240856 is an FDA 510(k) clearance for Hip Spacer Molds, manufactured by Osartis GmbH. The device is a Class 2 Orthopedic device with product code MBB cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K240856 · Osartis GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
237d
Days
Class 2
Risk

K240856 is an FDA 510(k) clearance for the Hip Spacer Molds. Classified as Bone Cement, Antibiotic (product code MBB), Class II - Special Controls.

Submitted by Osartis GmbH (Münster, DE). The FDA issued a Cleared decision on November 20, 2024 after a review of 237 days - an extended review cycle.

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 Osartis GmbH devices

FDA 510(k) Submission Details - K240856

510(k) Number K240856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2024
Decision Date November 20, 2024
Days to Decision 237 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
115d slower than avg
Panel avg: 122d · This submission: 237d
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 K240856.
SpaceFix Shoulder Spacer
K252443 · G21, S.R.L. · Sep 2025
GENTAFIX® (1, 3, 3MV)
K242216 · Teknimed Sas · Dec 2024
StageOne™ Select Hip Cement Spacer Molds
K222760 · Biomet, Inc. · Dec 2022
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