A Synopsis of the iData report which analyzes and evaluates the current state of the market including existing and potential markets, product average selling prices, and unit volumes. The report also highlights the opportunities and potential hazards involved, and presents strategies for successfully navigating the market landscape. Furthermore, it seeks to identify the trends and technologies that will affect the future of each market segment and prepares an unbiased critical assessment of such market drivers and limiters based on our “bottom up” approach, which includes primary and secondary research methods.

2. U.S. Market for Small
Bone & Joint Orthopedic
Devices
~ Report Synopsis ~

3. U.S. Market for Small Bone & Joint
Orthopedic Devices
In 2012, the total U.S. market for small bone and joint
orthopedic devices was valued at over $2 billion.
The U.S. small bone and joint orthopedic device market includes shoulder
reconstruction implants, elbow repair devices, hand and wrist devices, foot and
ankle devices and shape memory staples. All of these segments were
experiencing positive growth in 2012, as the aging population continued to drive
demand along with the increased awareness for small bone and joint
procedures. Capitated pricing has been affecting the shoulder reconstruction
and hand and wrist devices market segments, which is negatively impacting the
overall market. The ASPs of products in smaller market segments like the foot
and ankle devices and shape memory staples market segments however are
not being affected yet by capitated pricing. Overall, the strong positive growth in
all segments will allow the entire market to grow rapidly over the 2012–2019
forecast period.

4. U.S. Market for Small Bone & Joint Orthopedic
Device Market, U.S., 2009 – 2019
Annual Growth Rate (%)
Market Value (US$M)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
Year
Source: iData Research Inc.

5. Shoulder Reconstruction Market
In 2012, the reversed shoulder reconstruction market segment was the most
rapidly growing segment from the entire shoulder reconstruction market, with
a growth of 13.1% over 2011.
The shoulder reconstruction market is comprised of total shoulder implants, reversed shoulder
implants, partial shoulder implants, resurfacing implants and revision implants. Reversed
shoulder implants were the most rapidly growing segment of the combined shoulder
reconstruction market in 2012. Reversed shoulder implants are indicated for older patients with
osteoarthritis that do not have a rotator cuff or have an irreparable rotator cuff. People are also
starting to receive reversed shoulder implants for fractures instead of receiving hemi-
arthroplasty. Since the entire rotator cuff is torn off in a fracture, reversed shoulder implants are
being recommended by surgeons as a more suitable solution for this indication instead of
partial shoulder implants. As a result of this recommendation trend, partial shoulder implants
were declining in unit sales growth in 2012; some of the loss in procedure volume was being
converted to reversed shoulder procedures or total shoulder procedures. As procedure
volumes continue to climb, particularly for total and reversed shoulder implants, hospitals are
turning more and more toward capitated pricing which is causing a slight deterioration in ASPs.
However, since shoulder revision procedures are relatively low, they go more unnoticed by
hospitals and thus are not yet affected by capitated pricing. Thus, ASPs will continue to slowly
grow over the forecast period for the shoulder revision market segment.

6. Shoulder Reconstruction Market Growth by
Segment, U.S., 2012
Segment 1 Segment 2 Segment 3 Segment 4 Segment 5
Annual Growth Rate (%)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
Year
Source: iData Research Inc.

7. Elbow Repair Market
In 2012, the elbow plate and screw market segment represented the largest
portion of the total elbow repair market, exceeding revenue sales of $62.5
million.
The elbow repair market includes total elbow reconstruction prostheses, radial head
prostheses and elbow plates and screws (for the olecranon and distal humerus). In 2012, semi-
constrained total elbows were continuing to be adopted over unconstrained total elbows as
durability was a more pressing concern than the potential increase in mobility unconstrained
elbows offered. Unit sales of olecranon and distal humerus plates and screws were growing a
healthy rate as many radial head implant procedures also required use of these fracture repair
devices. Radial head implants were the most frequently used elbow joint replacement devices
in 2012. The radial head market has been increasing in competition over the past several
years; moreover, recent literature suggests that press-fit radial head prostheses that try to
create anatomic restoration of the joint do not have very good short to mid-term survival in
patients. They often need to be removed due to osteolysis of the proximal radius. Thus, non-
press-fit (cemented) radial heads are expected to see the most growth over the forecast period.
Capitated pricing has not yet affected ASP growth in the elbow repair market. The slow but
steady increase in prices will help fuel market growth along with the rise in procedures.

8. Elbow Repair Market by Segment, U.S., 2012
Segment 1 Segment 2 Segment 3
Average Selling Price (US$)
Number of Units Sold
Note: The size of the bubble indicates the size of the market.
Source: iData Research Inc.

9. Hand & Wrist Market
The hand and wrist market is expected to grow at a CAGR of 4.8%
over the forecast period, with wrist fusion plates being the fastest
growing segment in this market.
The hand and wrist device market includes total wrist implants, wrist fusion plates, distal
radius plates, ulnar head implants and hand digit implants. Although the wrist fusion
segment comprised of the lowest revenues in the hand and wrist market, it was the
fastest-growing segment of the total hand and wrist market in 2012 and is expected to
grow the fastest over the forecast period. This is due to recent skepticism of total wrist
arthroplasty (TWA) by many surgeons who are choosing to stay with wrist fusions as
the standard of care in most cases. Hand digit implant devices were the slowest
growing segment in the hand and wrist device market. These implants include
prostheses for the CMC, PIP and MCP joints with CMC thumb arthroplasties growing
the most rapidly of all the finger arthroplasties. The demand for these implants is
somewhat dampened by the increasing efficacy of rheumatoid arthritis drugs; however,
with more text messaging related injuries becoming prevalent and the ever rising aging
population, this market will still experience positive growth over the forecast period.
Due to the recent acquisition of Synthes, the global leader of the trauma market, by
Johnson & Johnson in June 2012, there has been a shift in market shares in both the
distal radius and wrist fusion market segments. Additionally, the acquisition of DePuy’s
Trauma business by Biomet, has given a considerable boost to Biomet’s total share of
the overall hand and wrist market.

10. Hand & Wrist Device Units Sold by
Segment, U.S., 2009 – 2019
Segment 1 Segment 2 Segment 3 Segment 4 Segment 5
2009
2010
2011
2012
2013
Year
2014
2015
2016
2017
2018
2019
Percent of Units Sold (%)
Source: iData Research Inc.

11. Foot & Ankle Device Market
The price of ankle replacement prostheses were over eight times higher than
that of ankle arthrodesis devices, and their increased use is expected to
continue to be a major contributor to the growth of the foot and ankle device
market over the forecast period.
The foot and ankle device market was the most highly segmented market in the small bone
and joint orthopedic device market and includes ankle prostheses, ankle arthrodesis screws,
forefoot and midfoot devices, subtalar implants, foot digit implants, hammertoe devices and
foot and ankle external fixators. Although the foot and ankle device market was one the
smallest in the total small bone and joint device market, it was also the most rapidly growing.
By 2019 it will surpass the size of the elbow repair market. Strong growth in the hammertoe
market due to increased efforts to educate patients about these procedures will be a large
contributor to overall foot and ankle market growth. Additionally, changes in the ankle
replacement market involving the increased adoption of three-piece mobile bearing devices
have been fueling market growth. There is a slight price premium on mobile bearing devices
and thus their continued adoption will contribute to foot and ankle market growth over the
forecast period. The ankle arthrodesis market growth is increasingly being limited by strong
growth of the ankle arthroplasty market as ankle replacements become more and more
accepted as an alternate procedure to treating ankle arthritis.

12. Percent of Units Sold, Foot & Ankle Device
Market, U.S., 2009 & 2019
Segment 1 Segment 2 Segment 3 Segment 4 Segment 5
Segment 6 Segment 7
2009 2019
Source: iData Research Inc.

13. Shape Memory Staple Market
In 2012, the shape memory staple market was largely driven by
unit growth. It will continue growing rapidly at a CAGR of 9.4%.
Staples are available in two popular forms: mechanical compression and shape
memory type staples. The shape memory staple consists only of those staples
made from nitinol materials that change their shape when they reach a
transition temperature that is higher than their storage temperature.
Compression staples are used for internal fixation and are designed to apply
static or dynamic compression to two planar surfaces of bone.
Shape memory staples are being increasingly preferred over mechanical
compression staples because they allow for consistent compression across the
fusion site, providing maximum force and allowing for better fusion to occur.
The temperature sensitivity and enduring holding power make shape memory
staples more attractive to surgeons than mechanical compression staples for
trauma fixation, especially in the foot/ankle region. The better performance of
these devices, which are priced at a premium, will continue to fuel strong
market growth. Although the ASPs have been growing very slowly, market
growth has been mainly driven by the rapid unit sales growth which will
continue to be the main driving force for growth in this market.

14. Unit & ASP Growth, Shape Memory Staple
Market, U.S., 2009 – 2019
Annual Growth Rate (%)
2009
2012
Year
2019
ASP Growth
Unit Growth
Source: iData Research Inc.

15. Leading Competitors
In 2012, the recently formed DePuy Synthes Companies of
Johnson & Johnson held the leading position in the small bone
and joint orthopedic device market largely due to their lead in
plate and screw devices for wrist, feet and elbow fracture repair.
DePuy Synthes are not usually considered to be a dominant competitor in the
small bone and joint orthopedic device market, yet they dominated the distal
radius plate segment, the olecranon and distal humerus plate segment, the
ankle arthrodesis segment and also the forefoot and midfoot device segment.
Although the devices in the aforementioned segments are trauma fixation
devices, they are also sold by a number of small joint specialist companies.
Another point of distinction is that although these two markets are more mature
than other extremity device segments, they have a broad clinical need, which
corresponds to greater overall sales revenues. Outside of these segments,
there is less disparity between market shares for the remaining segments of the
combined small bone and joint device market.
Contingent upon the EUs approval for Depuy’s acquisition of Synthes was that
DePuy would sell their Orthopedic Trauma business to Biomet. This initial
acquisition, that included the divisions in the U.S., U.K., Australia, New
Zealand, Japan and Switzerland, was finalized in June 2012. Since then,
Biomet have acquired all of DePuy’s trauma accounts and have maintained the
same pricing on these products to ensure a smooth transition. This acquisition
has given Biomet a strong boost in their market share of several small bone
and joint market segments in 2012.

16. Leading Competitors, Small Bone & Joint
Orthopedic Device Market, U.S., 2012
Others
DePuy Synthes
Source: iData Research Inc.