Cleared Traditional

K123619 - INTRABLOCK BIOBALL HIP SYSTEM (IBS)

K123619 is an FDA 510(k) clearance for INTRABLOCK BIOBALL HIP SYSTEM (IBS), manufactured by Merete Medical GmbH. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K123619 · Merete Medical GmbH · Orthopedic device
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May 2013
Decision
182d
Days
Class 2
Risk

K123619 is an FDA 510(k) clearance for the INTRABLOCK BIOBALL HIP SYSTEM (IBS). Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Merete Medical GmbH (Berlin, DE). The FDA issued a Cleared decision on May 24, 2013 after a review of 182 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Merete Medical GmbH devices

FDA 510(k) Submission Details - K123619

510(k) Number K123619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2012
Decision Date May 24, 2013
Days to Decision 182 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
60d slower than avg
Panel avg: 122d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 451
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K123619.
AVENIR CEMENTED HIP STEM
K131884 · Zimmer GmbH · Aug 2013
DYNASTY ACETABULAR SYSTEM WITH CERAMIC
K130376 · Wrightmedicaltechnologyinc · Jul 2013
CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS
K130343 · Corin USA · May 2013
CORIN METAFIX HIP STEM
K130634 · Corin USA · May 2013
PROFEMUR RENAISSANCE CLASSIC HIP STEM
K130984 · Wrightmedicaltechnologyinc · May 2013
BIOLOX DELTA CERAMIC FEMORAL HEADS
K130899 · Zimmer GmbH · May 2013