United Orthopedic Corp said today that it won FDA clearance for its E-XPE vitamin E highly cross-linked polyethylene hip liner. The Irvine, Calif.-based company said that the E-XPE is a next-gen version of its highly cross-linked polyethylene blended with vitamin E intended to improve wear resistance and maintain oxidative stability and mechanical properties. United Orthopedic […]
Zimmer Biomet recalls bone stimulators on contamination risk
Zimmer Biomet (NYSE:ZBH) recalled nearly 1,400 bone stimulators on the risk that they could be contaminated with bacteria or chemicals, the FDA said yesterday. The Class I recall, denoting the risk of serious injury or death, covers 1,360 implantable bone growth and spinal fusion stimulators made and distributed between February 2015 and March 2018, including Zimmer […]
SIG Medical wins FDA nod for Advantage Rib fracture repair device
SIG Medical said this week it won FDA 510(k) clearance for its AdvantageRib anterior system, a rib fracture system. The newly cleared AdvantageRib anterior system includes anatomically contoured titanium plates intended to closely fit patient anatomy and screws, and is intended to be used through a traditional anterior approach. The system also features straight plates […]
Colfax slides on $3.2B DJO Global buy, plan to ditch air & gas handling biz
Colfax (NYSE:CFX) shares took a hit today after the industrial giant offered $3.15 billion to acquire orthopedics company DJO Global and said it plans to sell off its air & gas handling business. Vista, Calif.-based DJO, which is owned by a private equity consortium headed up by Blackstone, last week posted losses of -$29.5 million on sales of […]
FDA clears Spinal Elements’ surface coating technology
Spinal Elements said that the FDA has issued 510(K) clearance for the macro-, micro-, and nano-surface structure of its Ti-Bond surface coating technology. The Carlsbad, Calif. company said that a number of products in its portfolio use Ti-Bond, including the most recently introduced Lucent XP height- and lordosis-expandable interbody device. Interbody fusion products with Ti-Bond […]
FTC clears Stryker, K2M tie-up early
K2M (NSDQ:KTWO) said today that the U.S. FTC granted early termination to the Hart-Scott-Rodino Antitrust Improvement Act of 1976 waiting period for its pending $1.4 merger with Stryker (NYSE:SYK). The termination of the HSR Act clears yet another hurdle to the union between the two companies, which will position K2M as a wholly owned subsidiary of Kalamazoo, […]
Wright Medical’s Q3 results top forecasts
Wright Medical (NSDQ:WMGI) yesterday beat the consensus for both sales and earnings with its third-quarter results and raised its outlook for the rest of 2018. The Memphis-based orthopedics firm slashed its losses by -67.8% to -$42.5 million, or -38¢ per share, on sales growth of 13.8% to $194.1 million for the three months ended Sept. […]
K2M shareholders approve Stryker merger
K2M (NSDQ:KTWO) said today that its shareholders approved its $1.4 billion merger with Stryker (NYSE:SYK) during a special meeting of stockholders. The deal calls for Kalamazoo, Mich.-based Stryker to pay $27.50 per share for each outstanding share of K2M, for a 27% premium over K2M’s average closing price during the 90 days of trading ended August 29. K2M […]
Report: Medacta readies for Swiss IPO
Swiss medtech company Medacta is preparing for an initial public offering on the SIX Swiss Exchange for next spring, according to a Reuters report. The deal is being led by Credit Suisse and Morgan Stanley and joined by JP Morgan and UBS, three people familiar with the matter told Reuters. Neither the company or the […]
FDA clears Shoulder Innovations’ InSet short stem shoulder repair system
Emerging medtech developer Shoulder Innovations said today it won FDA 510(k) clearance for its InSet Humeral Short Stem System intended for partial or total shoulder arthroplasty procedures. The newly cleared system is intended for use in treating degenerative, rheumatoid or traumatic arthritis in the shoulder and includes new features the Holland, Mich.-based company said address potential […]
Amedica rebrands as Sintx Technologies
Amedica (NSDQ:AMDA) said this week that it’s rebranding as Sintx Technologies to better reflect its core silicon nitride business. The Salt Lake City-based company said it plans to change its trading symbol on the NASDAQ exchange to “SINT” in early November. “The previous name, i.e., Amedica, has transferred to CTL Medical, which is now CTL-Amedica. […]
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