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DePuy, Stryker and Synthes Receive Most FDA Approvals YTDwhile Zimmer lags BY ROBIN R. YOUNG CFA, JUNE 21, 2004

Fill the salesman's bag. Advance the art and practice of orthopedics. Create superior returns for your shareholders. None of these are possible without the FDA's initial and ongoing approval. So far this year, the FDA has granted 214 orthopedic device approvals. If such data is an early sign of future revenue growth, then DePuy, Stryker and Synthes shareholders have reason to smile. Coming up strong are Exactech and Wright Medical. Lagging is Zimmer.

Of 214 orthopedic FDA approvals granted this year, 208 were 510(k)s for 97% of the total. Of the seventy four companies who have received the approvals, three firms clearly led the industry. These companies were, in rank order, DePuy (27), Stryker (25) and Synthes (17). Zimmer, with 9 approvals by early June, is off to a slow start. Immediately behind Zimmer in the rankings are Exactech and Wright Medical, with 6 approvals each, which given their comparative size (roughly 1/10th the size of Zimmer), was an impressive performance for the first half of the year.

Members of the HealthpointCapital Weekly Journal can access the complete list of approvals, companies, decision dates and approval codes by clicking here.

While DePuy is the YTD leader, it was its orthopedic and Mitek divisions that led the way with a combined 20 approvals. DePuy's other divisions receiving orthopedic approvals were: DePuy Spine (3), DePuy Ace (2), Codman (1) and Ethicon Endo (1). Among DePuy's key approvals in the first six months of 2004 were:

Stryker, with 25 approvals (24 on a 510(k) basis and 1 PMA) is having a very good year. Its Howmedica Osteonics division nailed down 14 approvals - more than, for example, Zimmer, Biomet, Sofamor Danek or Smith & Nephew. But probably the most important approval was its PMA to use the growth factor OP-1 in a limited spinal indication. The following Table lists some of Stryker's more notable approvals:

There were 6 PMA approvals so far this year; more than the 5 approved for all of last year. The recent PMA approvals were for:

And coming up strong were two small orthopedic companies: Exactech and Wright Medical. The full list is available to members here.