Cleared Traditional

K121636 - ZENITH

K121636 is an FDA 510(k) clearance for ZENITH, manufactured by Tgm Medical, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K121636 · Tgm Medical, Inc. · Orthopedic device
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Oct 2012
Decision
142d
Days
Class 2
Risk

K121636 is an FDA 510(k) clearance for the ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Tgm Medical, Inc. (El Dorado Hills, US). The FDA issued a Cleared decision on October 24, 2012 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 - K121636

510(k) Number K121636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2012
Decision Date October 24, 2012
Days to Decision 142 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
20d slower than avg
Panel avg: 122d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 477
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K121636.
ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
K121297 · Signature Orthopaedics Pty, Ltd. · Dec 2012
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
K112898 · Lima Corporate S.P.A. · Dec 2012
REVELATION POROUS COATED HIP STEM, SIZE 8
K122636 · Encore Medical, L.P. · Nov 2012
SMITH & NEPHEW SMF HIP STEM
K123012 · Smith & Nephew, Inc. · Oct 2012
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS
K123019 · Zimmer, Inc. · Oct 2012
INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
K122798 · Exactech, Inc. · Oct 2012