DePuy enters MoM resurfacing market

[Guest guest]

I received word today that a surgeon at Jewish General Hospital (McGill

University) in Montreal will be performing resurfacing surgeries this coming

week using a new MoM resurfacing device from DePuy. There have been 150 of

these done overseas, these will be the first in North America.

The device is going by the brand name " ASR " . DePuy received 510(k)

marketing clearance in December, 2003 for hemi-resurfacing using an ASR

brand femoral cap in the United States. This clearance was based on the

fact that it is " substantially similar " to the femoral cap used in the DePuy

TARA device and the Biomet cemented resurfacing femoral head. Unlike the

TARA device, the new ASR resurfacing under trial outside the US uses

metal-on-metal articulation.

Three of the five largest US large-joint replacement companies now have MoM

resurfacing components in the pipeline.

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[Guest guest]

Thanks for the information, .

I still can't figure out why couldn't use that same

" substantially similar " argument with the FDA for Conserve Plus - the

acetabular component comes from their Lineage line (I think), which is

approved, and the femoral component is approved for hemi-resurfacing,

and the metal on metal bearing surface seems to me to be

" substantially similar " to their BFH technology THR.

Not that there is any logic to the FDA processes . . .

> I received word today that a surgeon at Jewish General Hospital (McGill

> University) in Montreal will be performing resurfacing surgeries

this coming

> week using a new MoM resurfacing device from DePuy. There have been

150 of

> these done overseas, these will be the first in North America.

>

> The device is going by the brand name " ASR " . DePuy received 510(k)

> marketing clearance in December, 2003 for hemi-resurfacing using an ASR

> brand femoral cap in the United States. This clearance was based on the

> fact that it is " substantially similar " to the femoral cap used in

the DePuy

> TARA device and the Biomet cemented resurfacing femoral head.

Unlike the

> TARA device, the new ASR resurfacing under trial outside the US uses

> metal-on-metal articulation.

>

> Three of the five largest US large-joint replacement companies now

have MoM

> resurfacing components in the pipeline.

>

> -

[Guest guest]

I still can't figure out why couldn't use that same " substantially

similar " argument with the FDA for Conserve Plus - the metal on metal bearing

surface seems to me to be " substantially similar " to their BFH technology

THR.,

I think the C+ came before the BFH, so there was no BFH to be substantially

similar to. On the other hand, the BFH may have been approved because of the C+

or the Conserve hemi only?

Cindy

C+ 5/25/01 and 6/28/01

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