Cleared Traditional

K210607 - PALACOS R pro

K210607 is an FDA 510(k) clearance for PALACOS R pro, manufactured by Heraeus Medical GmbH. The device is a Class 2 Orthopedic device with product code LOD cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K210607 · Heraeus Medical GmbH · Orthopedic device
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Jul 2021
Decision
130d
Days
Class 2
Risk

K210607 is an FDA 510(k) clearance for the PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Heraeus Medical GmbH (Wehrheim, DE). The FDA issued a Cleared decision on July 9, 2021 after a review of 130 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 Heraeus Medical GmbH devices

FDA 510(k) Submission Details - K210607

510(k) Number K210607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2021
Decision Date July 09, 2021
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOD Device Classification - Class 2, Special Controls

Product Code LOD Bone Cement
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 - LOD Bone Cement

All 52
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K210607.
Bone Cement-Normal Viscosity
K212729 · Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda · May 2022
OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement
K211869 · Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE · May 2022
PALACOS MV pro
K213812 · Heraeus Medical GmbH · Feb 2022
BonOs Inject, Pedicle screw kits, Cement pusher
K202458 · Osartis GmbH · May 2021
BonOs HV, BonOs MV, BonOs LV
K210120 · Osartis GmbH · Mar 2021
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
K210125 · Osartis GmbH · Mar 2021