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R&D Recap: Leading Orthopaedic Device Company Product Initiatives

Acquisitions, divestitures, market entries and exits have all shaped product portfolios for many of the orthopaedic industry’s larger players, in recent years. In this article, we look at the ten companies that represent numbers six through 15 on our list of the largest device companies ranked by revenue. More specifically, we review their product development initiatives over the last 18 months to offer a good look at your competitors’ strategic priorities.

According to our estimates, these companies range in annual revenue from $250 million to $2 billion and their products cross all segments: joint reconstruction, spine, trauma, arthroscopy/soft tissue, orthobiologics. New product launches drove all but Aesculap and ConMed to post above-market growth of 3.2% in 2016 vs. 2015.


Top 15 Device Companies
 by Revenue*

1. DePuy Synthes
2. Zimmer Biomet
3. Stryker
4. Smith & Nephew
5. Medtronic
6. Arthrex
7. DJO
8. NuVasive
9. Aesculap
10. Wright Medical
11. Globus Medical
12. Orthofix
13. ConMed
14. Exactech
15. Acumed

*based on ORTHOWORLD® estimates


Arthrex, the leader in the arthroscopy/soft tissue market and the number four player in orthobiologics, according to our estimates, has signed distribution and product development agreements in those spaces, for instance renewing its long-term agreement with LifeNet Health to provide allograft implants and instrumentation and explore new applications, such as opportunities in cartilage repair, building on their co-development of alternatives to joint replacement. Arthrex also signed a new multi-year distribution agreement with Vivex Biomedical, following their co-development of BioCartilage, which they co-distribute, and was selected as CollPlant’s exclusive distributor for Vergenix STR soft tissue repair matrix in Europe, the Middle East, India and certain African countries.

DJO Global launched the AltiVate Anatomic Shoulder featuring P2, DJO’s proprietary “porous porous” coating designed to provide superior bone ingrowth. The system features a short humeral stem and a glenoid component with Drop and Go technology, encompassing trilobe features on the peripheral pegs for immediate fixation. The system joins the AltiVate next-gen reverse shoulder, which launched in 3Q15.

DJO has launched new shoulder, knee and hip products in the last two years, which has contributed to the company posting high growth in this segment at an increase of 27.5% in 2016 vs. 2015. In 2014, the company acquired Zimmer’s Discovery Total Elbow for the U.S. market.

NuVasive, which is projected to surpass $1 billion in revenue this year, continues to make investments in spine, trauma and pediatrics.

In April, the company launched RELINE Trauma, designed to offer intra-op customization in the treatment of spinal fractures. This is reportedly the first trauma system that can accommodate traditional open, Maximum Access Surgery (MAS) or hybrid procedures, depending on pathology and patient needs. A dual rack system supports independent lordosis restoration and parallel compression/distraction for ligamentotaxis, and allows procedures to be completed by one surgeon rather than two. The product is integrated with NuVasive’s computer assisted technologies.

Also in April, NuVasive received 510(k) clearance for UNYTE, a bone-compressing system to treat complex/poorly-healing fractures. Leadership expects that UNYTE could cannibalize ex-fix completely.

Aesculap activL
Aesculap activ-L

Aesculap has made two announcements related to its spine portfolio thus far in 2017. First, the company offered a warranty program for Plasmapore XP-coated spinal interbody fusion devices, reported to be the first facility risk-share agreement on a titanium-enhanced PEEK interbody in the spine industry to warrant against delamination of a surface enhancement and the ability to visualize an implant without artifact. This news accompanied the launch of the TSpace XP interbody system, which is treated with Plasmapore XP. 

Aesculap also presented long-term data from study of its activ-L artificial lumbar disc. Studies indicate that, at five years, activ-L had a protective effect on the progression of degenerative disc disease at adjacent levels in 91.2% of patients. The data reiterated the role of lumbar total disc replacement in delaying the progression of adjacent segment disease. 

Wright Medical launched Tornier’s BLUEPRINT computer-aided surgical planning software/patient-specific instruments. (Tornier had received FDA 510(k) clearance for the technology in 2015. BluePrint, along with Wright’s PROPHECY case planning software, helps to better forecast the exact instrumentation and implants needed for ease case. (Approximately 70% of procedures using Wright’s total ankle are completed with PROPHECY enabling technology.)

Wright Medical and Tornier continue their product line integration following their 2015 merge. In 2016, Tornier legacy hip and knee products were sold to Corin, as Wright sought to exit those markets completely.

Globus Medical seeks to derive 15% of its overall sales from trauma and robotics by 2020. In 1Q17, the company received its CE Mark for the Excelsius GPS robotic trajectory guidance and navigation system. GPS supports minimally invasive and open orthopaedic and neurosurgical procedures, with applications in the cervical spine, sacroilium, long bones, cranium, etc. The system integrates with the company’s own implants and instruments, and is compatible with pre-op CT, intra-op CT and fluoroscopic imaging modalities.

Globus has filed for GPS’ 510(k) clearance, and in May received a letter from FDA indicating that the company had not sufficiently addressed questions on its submission. Globus expedited a revised filing and expects to receive clearance within 2Q17. 

Orthofix launched the JuniOrtho brand to house products and services that treat pediatric orthopaedic and congenital deformities. The company’s pediatric extremity fixation offerings began with launch of a limb lengthener in the early 1980s. Today, its products include the TL HEX TrueLok Hexapod system and Guided Growth plates, available in >70 countries.

Orthofix PEMF
Orthofix PEMF

The company also announced FDA premarket approval and European CE Mark approval for next-generation CervicalStim and SpinalStim bone growth stimulators. U.S. availability will include the Stim onTrack mobile app to support patient engagement and real-time delivery of data to the physician. The Class III devices employ low-level pulsed electromagnetic field (PEMF), designed to activate and augment the body’s natural healing process, providing a noninvasive treatment to promote post-op spinal fusion.

Recently, NASS issued first-of-its-kind coverage recommendations for electrical bone growth stimulators, supporting use of PEMF stimulation devices as an adjunct to spinal fusion. Orthofix is conducting IDE clinical trials to collect safety and effectiveness data for the CervicalStim system in treating odontoid fractures and Physio-Stim for knee osteoarthritis.

ConMed introduced seven new products at AAOS: four they consider “minor” and three “major.” The major product launches include CuffLink Double Row rotator cuff repair system, diamond-like coated shaver blades and the Trinity 3-in-1 camera system, marketed as an economical option for ASCs and emerging markets.

ConMed has not posted positive quarterly growth since 4Q15. The company launched a turnaround initiative in 3Q16, which includes a revamp of marketing and a focused list of R&D projects and priorities.

Exactech divested its spine assets to ChoiceSpine earlier this year in order to focus exclusively on the joint reconstruction market. Spine represented a small portion of Exactech’s revenue in 2016 (about 3.3% by our estimates). The transaction allows Exactech to reallocate resources to joint recon, which grew at 8.6% in 2016 vs. 2015.

Thus far in 2017, Exactech has announced product developments for shoulder and knee. The company received FDA 510(k) clearance to market the ExactechGPS Shoulder Application, combining pre-op planning with computer-assisted surgery, and announced the first U.S. surgery with the Equinoxe Preserve humeral stem using the shoulder application. The company also announced completion of initial Truliant Knee procedures in its U.S. pilot launch. Truliant’s full U.S. launch is slated for 2018. The system offers a computer-assisted approach and ergonomic instrumentation that is designed to support accurate sizing and balancing during primary and revision procedures.

Acumed’s product launches have focused on expansion of its ankle and elbow lines. The company launched Ankle Plating System 3, comprising seven plate families that span the lateral, medial and posterior malleoli that are used in combination with the Acumed Small Fragment Base Set to treat fractures. Tension Band Pins and Acutrak AcuTwist Compression Screws are also included in the tray.

Acumed also released Slide-Loc Anatomic Radial Head System with a slide-loading design that does not require a set screw. The system also features a three-part implant design for increased modularity.

Certainly, this is not a full list of product clearances and launches by these companies. The products mentioned are meant to highlight the activity each company has prioritized through announcements. A more comprehensive list of company activity can be found in THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®.

Sources: Company press releases, websites and ORTHOWORLD estimates. Images courtesy of manufacturers