Cleared Traditional

K120599 - DEPUY M-SPEC 36MM FEMORAL HEADS

K120599 is an FDA 510(k) clearance for DEPUY M-SPEC 36MM FEMORAL HEADS, manufactured by Depuy Orthopaedics. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 427-day FDA review.

K120599 · Depuy Orthopaedics · Orthopedic device
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Apr 2013
Decision
427d
Days
Class 2
Risk

K120599 is an FDA 510(k) clearance for the DEPUY M-SPEC 36MM FEMORAL HEADS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Depuy Orthopaedics (Warsaw, US). The FDA issued a Cleared decision on April 30, 2013 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Depuy Orthopaedics devices

FDA 510(k) Submission Details - K120599

510(k) Number K120599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2012
Decision Date April 30, 2013
Days to Decision 427 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
305d slower than avg
Panel avg: 122d · This submission: 427d
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 485
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K120599.
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
K130099 · Encore Medical, L.P. · Jun 2013
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
K130149 · United Orthopedic Corporation · Jun 2013
UTF STEM, REDUCED
K123550 · United Orthopedic Corporation · May 2013
ARCOS TROCHANTER BUTTON
K130063 · Biomet, Inc. · Apr 2013
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