Cleared Traditional

K150576 - TGM Biolox delta Ceramic Heads

K150576 is an FDA 510(k) clearance for TGM Biolox delta Ceramic Heads, manufactured by Tgm Medical, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K150576 · Tgm Medical, Inc. · Orthopedic device
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Sep 2015
Decision
187d
Days
Class 2
Risk

K150576 is an FDA 510(k) clearance for the TGM Biolox delta Ceramic Heads. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Tgm Medical, Inc. (El Dorado Hills, US). The FDA issued a Cleared decision on September 9, 2015 after a review of 187 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 Tgm Medical, Inc. devices

FDA 510(k) Submission Details - K150576

510(k) Number K150576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2015
Decision Date September 09, 2015
Days to Decision 187 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 122d · This submission: 187d
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 477
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K150576.
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