Cleared Traditional

K172235 - CoreHip System

K172235 is an FDA 510(k) clearance for CoreHip System, manufactured by Aesculap Implants Systems, LLC. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K172235 · Aesculap Implants Systems, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
246d
Days
Class 2
Risk

K172235 is an FDA 510(k) clearance for the CoreHip® System. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Aesculap Implants Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on March 28, 2018 after a review of 246 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 Aesculap Implants Systems, LLC devices

FDA 510(k) Submission Details - K172235

510(k) Number K172235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2017
Decision Date March 28, 2018
Days to Decision 246 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
124d slower than avg
Panel avg: 122d · This submission: 246d
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 K172235.
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