Cleared Special

K061786 - VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS

K061786 is an FDA 510(k) clearance for VERSYS FIBER METAL MIDCOAT LOW HEAD CEN..., manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 28-day FDA review.

K061786 · Zimmer, Inc. · Orthopedic device
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Jul 2006
Decision
28d
Days
Class 2
Risk

K061786 is an FDA 510(k) clearance for the VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 24, 2006 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zimmer, Inc. devices

FDA 510(k) Submission Details - K061786

510(k) Number K061786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2006
Decision Date July 24, 2006
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 543
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K061786.
MONOBLOCK PRESS-FIT HIP STEM
K060072 · Omni Life Science, Inc. · Aug 2006
TRIDENT LARGE DIAMETER HIP SYSTEM
K061434 · Howmedica Osteonics Corp. · Aug 2006
TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE
K061226 · Zimmer, Inc. · Aug 2006
M-COR HIP REPLACEMENT SYSTEM
K053417 · Portland Orthopaedics Pty. , Ltd. · Jul 2006
ORTHOPEDIC SOURCE PRESS-FIT HIP
K061124 · Orthopedic Source, Inc. · Jul 2006
PCA 36MM FEMORAL HEADS
K061168 · Howmedica Osteonics Corp. · Jul 2006